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 .
Information Disclosure Statement
No IDS has been filed.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-8 in the reply filed on 29 June 2026 is acknowledged. The traversal is on the ground that the Groups are not patentably distinct and that there is no serious burden to examine all Groups. This is not found persuasive because the Groups are drawn to different statutory classes (machine, process, composition of matter) and are subject to a different classification and a different claim interpretation. For example, the method steps of Group II are considered as intended use recitations when presented in the context of the apparatus of Group I. An apparatus “configured to selectively intake…and expel” is treated differently than a method that requires specific intake and expulsion steps. There are functional language considerations that divide the examination of Groups I and II. As stated in the restriction requirement, the Groups are distinct because the apparatus of Group I could be used to practice a different method than that of Group II – i.e., a method that does not require the specific mixing of cell-alginate and cross-linker solutions in the second reservoir. As for the composition of Group III, it simply requires cell-laden hydrogel microstrands that could potentially be made from essentially any relevant apparatus or method, including those different from Group I and II. The composition is evaluated based on its inherent and physical characteristics, as opposed to its method of fabrication. Examination of the composition of Group III is entirely different and involves a comparison of prior art hydrogel materials, as opposed to prior art syringe systems when examining Groups I and II. There are significant product-by-process claim interpretation considerations that must be taken into account.
The requirement is still deemed proper and is therefore made FINAL.
Claims 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected Groups, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 29 June 2026.
In order to comply with 37 CFR 1.121, all future claim listings must indicate that claims 9-20 are withdrawn. In order to expedite prosecution, a notice of non-compliance has not been sent with this office action.
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Sahatjian (US 6629947) in view of Ahn (US 20190008606).
With respect to claim 1, Sahatjian discloses a device for fabricating alginate hydrogel microstrands. The device includes a first reservoir (Figure 2:22) comprising a cell-alginate solution (“the first flowable substance includes a bulking agent…most preferably, the bulking agent includes a polysaccharide, such as alginate”). Column 4, line 50 to column 5, line 2 further states that the cell-alginate solution includes autologous cells. A second reservoir (Figure 2:24) is in fluid connection with the first reservoir, and the second reservoir includes a cross-linker solution (“the reactant includes a cross-linking agent, the bulking agent and the reacting agent form a cross-linked polysaccharide fiber when they are mixed”). Mixing between the cross-linker solution and the cell-alginate solution procures cell-laden hydrogel microstrands. This mixing, however, occurs in a mixing chamber 60 of a cannula 40 (see Fig. 1), and it is unclear if Sahatjian shows that the second reservoir is configured to selectively intake the cell-alginate solution from the first reservoir and expel a combined cell-alginate solution and cross-linker solution therefrom.
Ahn discloses a device for fabricating hydrogel comprising a first reservoir (Figure 2:204) and a second reservoir (Figure 2:206). Hydrogel material is transferred between the two reservoirs repeatedly to generate uniform mixing using the reciprocating action of coordinated plungers (Figure 2:308, 310). Accordingly, the second reservoir is configured to selectively intake hydrogel material from the first reservoir and expel a combined solution therefrom.
Before the effective filing date of the claimed invention, it would have been obvious to intake cell-alginate solution from the first reservoir into the second reservoir of Sahatjian. Ahn shows that this produces a predictable and effective mixing effect that facilitates completion of the crosslinking reaction. Ahn indicates that repeated transfer of hydrogel agents between first and second reservoirs improves uniformity and generates a hydrogel product through a simplified plunger operation.
With respect to claim 2, Sahatjian and Ahn disclose the combination as described above. Sahatjian further teaches that the first and second reservoir are connected via a detachable nozzle (Figure 2:40). Similarly, Ahn shows that the first and second reservoirs are connected via a detachable nozzle (Figure 3:240).
With respect to claims 3 and 4, Sahatjian and Ahn disclose the combination as described above. The Sahatjian device may be used to combine cell-alginate solution and cross-linker solution at essentially any predetermined duration, including between 5 and 50 seconds. Apparatus claims cover what a device is, not what a device does. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114.
With respect to claim 5, Sahatjian and Ahn disclose the combination as described above. As previously discussed, both Sahatjian and Ahn each teach that the first and second reservoirs are syringes that each have a nozzle configured to create a fluidic coupling therebetween.
With respect to claim 6, Sahatjian and Ahn disclose the combination as described above. Sahatjian states that the cell-laden hydrogel material is suited for supporting endothelial cell growth. See column 10, lines 30-44. Sahatjian states that the cells in the cell-alginate solution may be autologous cells, which includes epithelial cells, endothelial cells and neural cells.
With respect to claim 7, Sahatjian and Ahn disclose the combination as described above. Sahatjian further states that the cross-linker solution includes calcium chloride.
With respect to claim 8, Sahatjian and Ahn disclose the combination as described above. Ahn shows that a filter (Figure 4:246) having micropatterned pores (Figure 4:249) is disposed between the first and second reservoirs.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,570,952.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of U.S. Pat. No. 12,570,952 include limitations drawn to
A device for fabricating alginate hydrogel microstrands, comprising:
a first reservoir including a cell-alginate solution therein, the first reservoir configured to selectively intake and expel the cell-alginate solution therefrom;
a second reservoir in fluid connection with the first reservoir, the second reservoir containing a cross-linker solution and configured to selectively intake the cell-alginate solution from the first reservoir and expel a combined cell-alginate solution and cross-linker solution therefrom; and
wherein the second reservoir configured to selectively expel the combined cell- alginate solution and cross-linker solution as cell-laden hydrogel microstrands.
Claims 1 and 14 of U.S. Pat. No. 12,570,952 include limitations drawn to a similar system comprising a first reservoir configured to hold an alginate solution and a second reservoir configured to hold a cross-linker solution. Claims 1 and 14 of U.S. Pat. No. 12,570,952 further state that the system is configured to create microfibers, and that the first and second reservoirs are arranged as syringes connected via an adapter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Epstein (US 5226877), Antanavich (US 5814022) and Whitmore (US 5674394) references disclose the state of the art regarding syringe coupling systems.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN A BOWERS/ Primary Examiner, Art Unit 1799
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