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 .
Status of Claims and Application
This non-final action on the merits is in response to the election of invention received by the office 05 February 2026. Claims 1, 6, 8, 17, 18, 21, 28, 29, 34-36, 38, 40-42, 46 and 51 are pending. Claims 36, 38, 40-42 and 51 are withdrawn as non-elected.
Election/Restrictions
Claims withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected 36, 38, 40-42 and 51, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05 February 2026.
Applicant's election with traverse of the invention of group I (claims 1, 6, 8, 17, 18, 21, 28, 29 34, 35, and 26) in the reply filed on 05 February 2026 is acknowledged. The traversal is on the ground(s) that the amendment of claims 1 and 38 distinguish over U.S. Patent,3,767,085 which was cited to demonstrate the claims non-contribution to the art. This is not found persuasive because although applicant is correct that the ‘085 reference does not teach and is not capable of performing the amended claims newly recited intended use, the claims still do not make a contribution over available prior art as demonstrated below.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 4 is objected to. In the claim set received by the office 05 February 2026, claim 4 is listed as both cancelled and pending. Applicants remarks of the same date indicate that applicant intended to cancel claim 4. Cancellation would be consistent with applicant’s amendment of claim 1 on that date, which incorporates the entirety of claim 4. For the purposes of examination, claim 4 will be regarded as presently presented as it is still written on the page. Applicant is requested to properly indicate the status of claim 4 as cancelled in the next response to the office.
Claim Rejections - 35 USC § 112
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 only limitations which are already fully set forth in claim 1, from which it immediately 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.
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, 4, 6, 8, 17, 18, 21, 28, 29 34, 35, and 46 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by applicant admitted prior art.
Applicant admits that a commercially available syringe coupled to an additive manufacturing apparatus available for public sale since 2017. See section 2.2 Experimental Confirmation of Gradient Formation using Dispense Plotting – Page 58 of specification as originally filed and attached web archive of the web page https://web.archive.org/web/20171204231348/https://www.regenhu.com/3d-bio-printers/#3DDiscovery indicating that the printer disclosed by applicant was publicly available for sale on at least 04 December 2017.
Regarding claims 1 and 4, applicant discloses admits as prior art an apparatus with the same structure claimed and as being able to be used in the manner claimed. Applicant is reminded that although recitations of intended use are not accorded patentable weight, the prior art apparatus must be capable of being employed in the manner claimed. In stating that the results produced by this apparatus are congruent with the simulated outcomes applicant prepared, applicant has confirmed the suitability of the applicant admitted prior art apparatus.
Regarding claim 35, ‘applicant describes the admitted prior art 3 cc syringe with 20 ga needle as a “printer cartridge.”
Regarding claim 36, applicant discloses the printer in the cited passage of the specification.
Regarding claim 46, applicant discloses the reservoir as well as ancillary equipment of various types in the cited passage of the specification.
The remaining dependent claims are directed exclusively to statements of material worked upon, recitations of intended use or combinations of the two, as laminar flow regimes are dictated by both operating conditions and physical material properties. (See MPEP 2114 (II) and 2115 for guidance regarding intended uses of claimed apparatuses and material worked upon by claimed apparatuses.)
See MPEP 2129 for guidance regarding applicant admitted prior art.
Claim(s) 1, 4, 6, 8, 17, 18, 21, 28, 29 34, 35, and 46 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication 2005/0082204 to Schwartz et al. (‘204 hereafter).
Regarding claim 1, ‘204 teaches a reservoir comprising (i) a reservoir body defining an interior space of the reservoir, wherein a content is arranged in the interior space of the reservoir, and (ii) an outlet, wherein the reservoir is configured to dispense the content from the reservoir through the outlet by pressurising the content in the interior space of the reservoir, and wherein the content comprises a first flowable composition comprising a first material, and a second flowable composition comprising a second material, wherein the reservoir is configured such that, upon pressurisation of the content, the first flowable composition and the second flowable composition are dispensed through the outlet simultaneously in a laminar flow, thereby forming a non-plane boundary surface between the first flowable composition and the second flowable composition (Fig 4, items 3 and 1 and 2 and 4 Examiner’s note: the non-plane boundary in this prior art is an annulus, as shown in cross section by figure 3). Applicant is reminded that recitations of intended use do not further limit claimed apparatuses over the prior art. The cited prior art is capable of being used in the manner claimed.
Regarding claim 4, ‘204 teaches the reservoir wherein the reservoir is configured such that pressurisation of the content results in a non-plane boundary surface between the first flowable composition and the second flowable composition (Fig 1, item14 Examiner’s note: the non-plane boundary in this prior art is an U-shape, as shown in cross section by figure 2). Applicant is reminded that recitations of intended use do not further limit claimed apparatuses over the prior art. The cited prior art is capable of being used in the manner claimed.
Regarding claim 6, ‘204 teaches the reservoir wherein the non-plane boundary surface has a U-shaped cross section (Fig 2 item 34).
Regarding claim 7, ‘204 teaches the reservoir wherein the reservoir is configured to dispense the content from the reservoir through the outlet with a laminar flow insofar as this is a recitation of intended use of the claimed apparatus and the prior art apparatus is capable of being used in the manner claimed.
Regarding claim 8, ‘204 teaches the reservoir wherein the reservoir is configured to dispense the content from the interior space through the outlet such that the dispensed content can exhibit a gradient or change in the proportion of the first flowable composition and the proportion of the second flowable composition in the dispensed content insofar as this is a recitation of intended use of the claimed apparatus and the prior art apparatus is capable of being used in the manner claimed. The ‘204 reference teaches that the material supplies 5 and 6 are independently controllable.
Regarding claim 17, ‘204 teaches the reservoir of claim 1, wherein the first flowable composition and/or the second flowable composition comprise one or more additives insofar as this is a statement of material worked upon by a claimed apparatus. Applicant is reminded that statements of material worked upon do not further limit apparatus claims. The prior art apparatus may be employed with first or second compositions which either or both contain additives.
Regarding claim 18, ‘204 teaches the reservoir wherein the first material and the second material are identical or different from each other insofar as this is a statement of material worked upon by a claimed apparatus. Applicant is reminded that statements of material worked upon do not further limit apparatus claims. The prior art apparatus may be employed with first or second compositions which either the same or different compositions.
Regarding claim 21, ‘204 teaches the reservoir wherein the difference between the first material and the second material is in the type, structure, concentration, and/or viscosity of the first material and the second material insofar as this is a statement of material worked upon by a claimed apparatus. Applicant is reminded that statements of material worked upon do not further limit apparatus claims. The prior art apparatus may be employed with first and second compositions as claimed.
Regarding claim 28, ‘204 teaches the reservoir wherein the first material is selected from the group consisting of a silk polypeptide, hyaluronic acid, silicone, collagen, alginate, gelatin, gelatin with methacrylated groups (GelMA), heparin, chondroitin sulfate, chitosan, and cellulose, preferably nanocellulose, and/orthe second material is selected from the group consisting of a silk polypeptide, hyaluronic acid, silicone, collagen, alginate, gelatin, gelatin with methacrylated groups (GelMA), heparin, chondroitin sulfate, chitosan, and cellulose, preferably nanocellulose insofar as this is a statement of material worked upon by a claimed apparatus. Applicant is reminded that statements of material worked upon do not further limit apparatus claims. The prior art apparatus may be employed with first or second materials as claimed.
Regarding claim 29, ‘204 teaches the reservoir wherein the first material comprised in the first flowable composition is a silk polypeptide and the second material comprised in the second flowable composition is a silk polypeptide, wherein the first flowable composition or the second flowable composition comprises one or more additives insofar as this is a statement of material worked upon by a claimed apparatus. Applicant is reminded that statements of material worked upon do not further limit apparatus claims. The prior art apparatus may be employed with first or second materials as claimed.
Regarding claim 34, ‘204 teaches the reservoir wherein the first flowable composition is a hydrogel, and/or the second flowable composition is a hydrogel insofar as this is a statement of material worked upon by a claimed apparatus. Applicant is reminded that statements of material worked upon do not further limit apparatus claims. The prior art apparatus may be employed with first or second compositions as claimed.
Regarding claim 35, ‘204 teaches the reservoir wherein the reservoir is a cartridge (Fig 1 item 12).
Regarding claim 46, ‘204 teaches a kit comprising the reservoir (Fig 1).
Claim(s) 1, 4, 6, 8, 17, 18, 21, 28, 29 34, 35, and 46 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP S6065285 A to Yoshiaki Shimizu (‘285 hereafter).
Regarding claim 1, ‘285 teaches a reservoir comprising (i) a reservoir body defining an interior space of the reservoir, wherein a content is arranged in the interior space of the reservoir, and (ii) an outlet, wherein the reservoir is configured to dispense the content from the reservoir through the outlet by pressurising the content in the interior space of the reservoir, and wherein the content comprises a first flowable composition comprising a first material, and a second flowable composition comprising a second material, wherein the reservoir is configured such that, upon pressurisation of the content, the first flowable composition and the second flowable composition are dispensed through the outlet simultaneously in a laminar flow, thereby forming a non-plane boundary surface between the first flowable composition and the second flowable composition (Fig 4, items 3 and 1 and 2 and 4 Examiner’s note: the non-plane boundary in this prior art is an annulus, as shown in cross section by figure 3). Applicant is reminded that recitations of intended use do not further limit claimed apparatuses over the prior art. The cited prior art is capable of being used in the manner claimed.
Regarding claim 4, ‘285 teaches the reservoir wherein the reservoir is configured such that pressurisation of the content results in a non-plane boundary surface between the first flowable composition and the second flowable composition (Fig 4, items 3 and 1 and 2 and 4 Examiner’s note: the non-plane boundary in this prior art is an annulus, as shown in cross section by figure 3). Applicant is reminded that recitations of intended use do not further limit claimed apparatuses over the prior art. The cited prior art is capable of being used in the manner claimed.
Regarding claim 6, ‘285 teaches the reservoir wherein the non-plane boundary surface has a U-shaped cross section (Fig 3, items 1 and 3).
Regarding claim 7, ‘285 teaches the reservoir wherein the reservoir is configured to dispense the content from the reservoir through the outlet with a laminar flow insofar as this is a recitation of intended use of the claimed apparatus and the prior art apparatus is capable of being used in the manner claimed.
Regarding claim 8, ‘285 teaches the reservoir wherein the reservoir is configured to dispense the content from the interior space through the outlet such that the dispensed content can exhibit a gradient or change in the proportion of the first flowable composition and the proportion of the second flowable composition in the dispensed content insofar as this is a recitation of intended use of the claimed apparatus and the prior art apparatus is capable of being used in the manner claimed. The ‘285 reference teaches that the material supplies 5 and 6 are independently controllable.
Regarding claim 17, ‘285 teaches the reservoir of claim 1, wherein the first flowable composition and/or the second flowable composition comprise one or more additives insofar as this is a statement of material worked upon by a claimed apparatus. Applicant is reminded that statements of material worked upon do not further limit apparatus claims. The prior art apparatus may be employed with first or second compositions which either or both contain additives.
Regarding claim 18, ‘285 teaches the reservoir wherein the first material and the second material are identical or different from each other insofar as this is a statement of material worked upon by a claimed apparatus. Applicant is reminded that statements of material worked upon do not further limit apparatus claims. The prior art apparatus may be employed with first or second compositions which either the same or different compositions.
Regarding claim 21, ‘285 teaches the reservoir wherein the difference between the first material and the second material is in the type, structure, concentration, and/or viscosity of the first material and the second material insofar as this is a statement of material worked upon by a claimed apparatus. Applicant is reminded that statements of material worked upon do not further limit apparatus claims. The prior art apparatus may be employed with first and second compositions as claimed.
Regarding claim 28, ‘285 teaches the reservoir wherein the first material is selected from the group consisting of a silk polypeptide, hyaluronic acid, silicone, collagen, alginate, gelatin, gelatin with methacrylated groups (GelMA), heparin, chondroitin sulfate, chitosan, and cellulose, preferably nanocellulose, and/orthe second material is selected from the group consisting of a silk polypeptide, hyaluronic acid, silicone, collagen, alginate, gelatin, gelatin with methacrylated groups (GelMA), heparin, chondroitin sulfate, chitosan, and cellulose, preferably nanocellulose insofar as this is a statement of material worked upon by a claimed apparatus. Applicant is reminded that statements of material worked upon do not further limit apparatus claims. The prior art apparatus may be employed with first or second materials as claimed.
Regarding claim 29, ‘285 teaches the reservoir wherein the first material comprised in the first flowable composition is a silk polypeptide and the second material comprised in the second flowable composition is a silk polypeptide, wherein the first flowable composition or the second flowable composition comprises one or more additives insofar as this is a statement of material worked upon by a claimed apparatus. Applicant is reminded that statements of material worked upon do not further limit apparatus claims. The prior art apparatus may be employed with first or second materials as claimed.
Regarding claim 34, ‘285 teaches the reservoir wherein the first flowable composition is a hydrogel, and/or the second flowable composition is a hydrogel insofar as this is a statement of material worked upon by a claimed apparatus. Applicant is reminded that statements of material worked upon do not further limit apparatus claims. The prior art apparatus may be employed with first or second compositions as claimed.
Regarding claim 35, ‘285 teaches the reservoir wherein the reservoir is a cartridge (Fig 4 item 8).
Regarding claim 46, ‘285 teaches a kit comprising the reservoir (Fig 4).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John P Robitaille whose telephone number is (571)270-7006. The examiner can normally be reached Monday-Friday 8:30AM-6:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Galen Hauth can be reached at (571) 270-5516. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JPR/Examiner, Art Unit 1743
/GALEN H HAUTH/Supervisory Patent Examiner, Art Unit 1743