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 final action on the merits is in response to the remarks and amendment received by the office 09 July 2026. Claims 1, 6, 7, 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 Claims 36, 38, 40-42 and 51 are withdrawn as non-elected. Claims 1 and 38 are amended. Claim 4 is cancelled. No claims are added.
Response to Amendment
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 pressurizing 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 first flowable composition and the second flowable composition are arranged within the interior space as separate regions sharing a common boundary surface prior to pressurization, wherein the common boundary surface extends across at least a portion of a cross-section of the interior space, wherein the first flowable composition and the second flowable composition are not mixed prior to pressurization wherein the reservoir is configured such that, upon pressurization 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 wherein neither the first flowable composition nor the second flowable composition surrounds the other (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. Applicant should carefully review MPEP sections 2114 (II) for guidance regarding the effect the manner of operating a claimed apparatus has on patentability and 2115 for guidance regarding the patentability of claims directed to material or article worked upon.
Regarding claim 4, ‘204 teaches the reservoir wherein the reservoir is configured such that pressurization 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 a 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 are 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/or the 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 pressurizing 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 first flowable composition and the second flowable composition are arranged within the interior space as separate regions sharing a common boundary surface prior to pressurization, wherein the common boundary surface extends across at least a portion of a cross-section of the interior space, wherein the first flowable composition and the second flowable composition are not mixed prior to pressurization, wherein the reservoir is configured such that, upon pressurization 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 wherein neither the first flowable composition nor the second flowable composition surrounds the other (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. Applicant should carefully review MPEP sections 2114 (II) for guidance regarding the effect the manner of operating a claimed apparatus has on patentability and 2115 for guidance regarding the patentability of claims directed to material or article worked upon.
Regarding claim 4, ‘285 teaches the reservoir wherein the reservoir is configured such that pressurization 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 are 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/or the 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).
Response to Arguments
The previously presented claim objections and rejections under 35 USC 112(d) are withdrawn as moot due to applicant’s cancellation of claim 4.
In support of the patentability of the instant claims, applicant has argued that the intended use of the claimed apparatus and the particulars of the material acted upon by the claimed apparatus distinguish it over the previously and applied prior art. Examiner disagrees. The claimed content, comprising first and second flowable compositions respectively comprising first and second materials is not a part of the claimed apparatus, but a material worked upon by the claimed apparatus. The cited prior art reservoirs are capable of being used in the manner claimed. Applicant’s remarks are silent with respect to this finding – preferring to further explain the alleged novelty of the claimed material worked upon and manner of use. Applicant is reminded that once examiner has explained how the cited prior art structure inherently meets the functional limitation, applicant must establish that the prior art cannot be used in the manner claimed (SEE MPEP 2114 (I)).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 John P Robitaille whose telephone number is (571)270-7006. The examiner can normally be reached Monday-Friday 8:30AM-6:00PM.
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, 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.
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.
/JPR/Examiner, Art Unit 1743
/GALEN H HAUTH/Supervisory Patent Examiner, Art Unit 1743
Prosecution Insights