DETAILED ACTION
Response to Amendment
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/31/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1 and 17-18 are objected to because of the following informalities:
Please amend claim 1 as follows to cure the remaining deficiencies (to differentiate between the plunger of the printer and the plungers of the syringes and to cure minor antecedent basis issues):
1. (Currently Amended) A printer for depositing material, said printer comprising:
a syringe holder defining at least two longitudinally-extending channels configured to receive and longitudinally constrain at least two syringes in predetermined spatial relationship, each syringe of the at least two syringes containing a respective component of said material and havinq a respective barrel and a respective plunger for dispensinq a respective material from its barrel via a respective outlet;
a printer plunger defining at least two bosses for abutting the plungers of the at least two syringes supported in said at least two longitudinally-extending channels; and
an injector comprising at least two connectors, each connector configured to connect to a respective one of said at least two syringes, said injector defining at least two internal passages connectable to said at least two syringes by said at least two connectors, at least one of said internal passages terminating at a distal tip of said injector;
wherein said injector has a proximal end and a distal end and at least a portion of said at least two internal passages extend coaxially within said injector, and wherein said at least two internal passages are not fully coextensive but instead define a common mixing portion internally to said injector adjacent a distal end of one of said at least two internal passages, said common mixing portion having a length configured to provide one of a desired mixing time and a desired cross-linking time for component materials carried by the at least two syringes, for a given flow rate through the common mixing portion of said injector.
Please amend claim 17 as follows to cure the remaining deficiencies (to differentiate between the plunger of the printer and the plungers of the syringes and to cure minor antecedent basis issues):
17. (Currently Amended) A printer for depositing material, said printer comprising:
a syringe holder defining at least two longitudinally-extending channels configured to receive and longitudinally constrain at least two syringes in predetermined spatial relationship, each syringe of the at least two syringes containing a respective component of said material and having a respective barrel and a respective plunger for dispensing a respective material from its barrel via a respective outlet;
a printer plunger defining at least two bosses for abutting the plungers of the at least two syringes supported in said at least two longitudinally-extending channels;
an injector comprising at least two connectors, each connector configured to connect to a respective one of said at least two syringes, said injector defining at least two internal passages connectable to said at least two syringes by said at least two connectors, at least one of said internal passages terminating at a distal tip of said injector; and
a leadscrew mechanism supported on said syringe holder and operable to mechanically drive said printer plunger with mechanical advantage.
In claim 18, please replace “said plunger” with “said printer plunger” (both recitations).
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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) 1-11are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Richards et al. (US 2007/0191781; hereafter Richards).
In regard to claim 1, Richards discloses a printer (310; “printer” is interpreted as intended use; Richards teaches delivering fibrin sealants which can be deposited in layers thereby meeting the limitation of printing) for depositing material from syringes (330) having a barrel (331, 331’) and a plunger (336, 336’) for dispensing material from the barrel via an outlet, said printer comprising: a syringe holder (322) defining at least two longitudinally-extending channels (see Figure 4; 322 includes space for each barrel) configured to receive and longitudinally constrain at least two syringes in predetermined spatial relationship (see Fig. 6), each syringe containing a respective component of said material; a plunger (334, 334’) defining at least two bosses (the extended body of plunger) for abutting at least two plungers of at least two syringes supported in said at least two longitudinally-extending channels; and an injector (360, 382, 381) comprising at least two connectors (361, 361’), each configured to connect to a respective one of said syringes (see Fig. 5), said injector defining at least two internal passages (365, 366, 381) connectable to said syringes by said connectors, at least one of said internal passages terminating at a distal tip of said injector (passage ends at 381’), wherein said injector has a proximal end and a distal end and at least a portion of said at least two internal passages extend coaxially within said injector, and wherein said at least two internal passages are not fully coextensive but instead define a common mixing portion internally to said injector adjacent a distal end of one of said at least two internal passages (see par. [0059] and Figs. 1a-1c), said mixing portion having a length configured to provide one of a desired mixing time and a desired cross-linking time for component materials carried by the syringes, for a given flow rate through the common mixing portion of said injector (any space between the distal end of the inner and outer needles creates a mixing portion that provides a mixing time and cross-linking time).
In regard to claim 2, Richards discloses wherein each of said at least two longitudinally- extending channels is dimensioned to receive one of a 1 mL syringe, a 3 mL syringe, a 5mL syringe and a 10mL syringe (see par. [0077]).
In regard to claim 3, Richards disclose wherein said at least two longitudinally-extending channels are dimensioned to receive syringes having different volumes (see par. [0077]-[0081]; the examiner notes that any syringe can have N number of volumes- for example, a max 3 ml syringe can be filled with N volumes between 0 and 3 ml).
In regard to claim 4, Richards discloses wherein said at least two longitudinally-extending channels are dimensioned to receive syringes having matching volumes (see Figure 4; the syringes are identically sized).
In regard to claim 5, Richards wherein said at least two longitudinally-extending channels extend along parallel axes (see Fig. 4).
In regard to claim 6, Richards discloses wherein said syringe holder (322) defines at least one socket (see opening for cartridge 330) dimensioned for receiving a barrel flange of a syringe to longitudinally constrain said syringe.
In regard to claim 7, Richards discloses wherein said syringe holder (322) defines a shoulder (see shoulders at proximal and distal ends of opening for cartridge 330) positioned to abut a portion of the barrel of a syringe to longitudinally constrain said syringe (see Figs. 4 and 7).
In regard to claim 8, Richards discloses wherein said shoulder is positioned to abut a barrel flange of the syringe (see Figs. 4 and 7).
In regard to claim 9, Richards discloses wherein said shoulder is positioned to abut a fitting of the syringe (see Figs. 4 and 7).
In regard to claim 10, Richards discloses wherein said at least two bosses of said plunger are connected by a common base (350) to form an integral unit (see Fig. 4).
In regard to claim 11, Richards discloses wherein said syringe holder (322) has a proximal end and a distal end, and wherein said syringe holder defines at least one through-bore extending and open to both its proximal end and its distal end (opening where cartridge 330 sits; open at the proximal and distal ends; see Fig. 4).
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Richards.
The instant disclosure describes the parameters of distance from the distal end of the syringe holder as being merely preferable, and does not this feature as contributing any unexpected results to the system. As such, parameters such as the distance from the distal end of the syringe holder are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed that the limitation of the distance from the distal end of the syringe holder would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Allowable Subject Matter
Claims 17-20 are allowable predicated upon the resolution of the claim objections.
The following is an examiner’s statement of reasons for allowance: The examiner agrees with the applicant’s argument that Richards does not disclose a leadscrew mechanism as is recited in the claims.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed 9/25/2025 have been fully considered but they are not persuasive.
In response to the applicant’s argument that Richards does not disclose recited mixing portion of claim 1, the examiner respectfully disagrees. The portion defined by the end of the inner needle to the end of the outer needle creates a mixing portion that will allow the material from the syringes to mix and cross-link (see par. [0059] and the corresponding figures). For this reason, the examiner maintains the rejection.
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 THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783