DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-10 and 12-20, and the species of PEGDA 3400 and polyethyleneimine in the reply filed on 7/6/2026 is acknowledged.
Claims 2-10, 14, 15, 18-20, 22, and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (claims 22, 31) or nonelected species (claims 2-10, 14, 15, 18-20), there being no allowable generic or linking claim.
Drawings
The drawings are objected to for the following reasons.
37 CFR 1.84(u)(1) states that “[T]he different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter” (emphasis added). Note that the drawings contain multiple instances wherein the drawing number of a partial view improperly includes a number after the capital letter (see FIG. 2C-1 to FIG. 2C-8; FIG. 3G-1 to FIG. 3G-3).
Further note that multiple drawings contain blurred, illegible text. See FIG. 2C-1 to 2C-5, 3C, 3F, 3G-1, 3G-3.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 12, 13, 16, 17 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.
Regarding claim 12: Claim 12 depends from claim 1 and recites limitations requiring that the synthetic bioink comprises one or more of listed components in specified amounts. Note, however, that claim 12 recites these amounts as a percentage without specifying the type of percent (e.g. weight percent, volume percent, mole percent). The claim is therefore indefinite, as it is unclear how to determine whether a composition comprises the recited components in the required amounts.
Claim 12 further recites the abbreviations “HPA”, PEGDA”, and “NAP”; note that the specification does not define these abbreviations. It is therefore unclear what compounds they are intended to refer to.
Furthermore, note that the claim recites the limitation UV386A. An online search indicates that this appears to be a trademark or a tradename for a commercially available ultraviolet absorbing dye. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. Accordingly, the use of the term UVA386A to identify a component of the claimed composition is indefinite.
Claims 13, 16, and 17 depend from claim 12 and do not correct this deficiency. The claims are therefore indefinite per the same rationale as claim 12.
Regarding claim 16: Claim 16 recites a limitation regarding the molecular weight of the polyethyleneimine polymer; however, the claim does not specify the units of said molecular weight (e.g., g/mol, kg/mol, etc.). The scope of the claim is therefore unclear.
Regarding claim 17: Claim 17 recites a limitation regarding the amount of polyethyleneimine (PEI) as a percentage, but does specify the type of percentage it is intended to be. Per the same rationale as outlined above with respect to claim 12, the instant claim is indefinite as it is unclear how to determine whether a composition comprises PEI in the required amount.
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, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Utama et al, WO2020/019022.
Utama discloses the production of a 3D-printed, crosslinked hydrogel made using bioink(s) (for claim 1) comprising a maleimide-functional polymer and a bis-thiol containing crosslinking agent (title, abstract).
Example 8 of Utama (¶0166-0170) discloses the production of a crosslinked hydrogel made from the combined use of first and second bioinks. Said first bioink comprises a maleimide-functional polyethylene glycol (PEG) (see ¶017 wherein PEG is stated to be an abbreviation for polyethylene glycol), corresponding to the primary polymer network (for claim 1) (Example 1a: ¶0151-0155). The second bioink comprises a bis-thiol functional PEG, corresponding to the claimed secondary polymer network (for claim 1) (see Example 2a: ¶0158-0160).
Regarding the requirement that the primary and secondary networks are bonded to one another: As noted above, the prior art hydrogel comprises a maleimide-functional PEG and a thiol-functional PEG. Utama teaches that the curing step results in reaction between these functional groups to form crosslinks-i.e., the maleimide-functional PEG and the thiol-functional PEG become bonded with one another to form an interpenetrating network (for claim 1).
Regarding claim 12: Note that, as written, claim 12 states that the bioink comprises “one or more of” the recited species; the claim therefore only requires that one of the recited components be present in the recited amount. Utama teaches that both bioinks were prepared using phosphate buffered saline (¶0153, 0158; see also ¶0127 defining PBS as phosphate buffered saline). One of ordinary skill in the art will recognize that phosphate buffered saline is an aqueous solution; the prior art bioinks therefore correspond to the claimed invention comprising water in balance.
Regarding claim 13: One of ordinary skill in the art will recognize that polyethylene oxide and polyethylene glycol are names for the polymer. The use of the polyethylene glycol polymers in the first and second bioinks therefore correspond to the claimed invention wherein the polymer comprises polyethylene oxide.
Claim Rejections - 35 USC § 102/103
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) 1, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Martinez et al, WO2020/077118.
Martinez discloses a double network bioink (for claim 1) that is printed and crosslinked (for claim 1) (¶00052). Embodiment 3 of said bioink (¶0008, 0006) is a composition comprising a thickener which is polyethylene oxide, a polyethylene glycol based network, and optional additives. The thickener and polyethylene glycol form two interpenetrating networks (¶0006), corresponding to the claimed primary and secondary polymer networks (for claim 1).
Regarding claim 12: As noted earlier in this Action, the phrase “one or more of” as recited in claim 12 only requires that one of the recited components be present in the recited amount. Martinez teaches that the prior art bioink comprises water, corresponding to the claimed limitation of water as a balance (¶00050).
Alternatively, note that the thickener may be present in an amount of 0.1 to 20 w/v%, overlapping the claimed range for the amount of polymer (¶00050). It has been held that in the case where the claimed ranges overlap or lie inside ranges disclosed in the prior art, a prima facie case of obviousness exists; see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages; see In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (" (MPEP § 2144.05). It therefore would have been obvious to prepare a bioink comprises the required amount of polyethylene oxide thickener in view of the teachings of Martinez.
Finally, note that the prior art bioink 1) can comprise PEGDA as the crosslinker in an amount in the range of 0.1 to 10 w/v% (¶00050) and 2) said PEGDA crosslinker may have a molecular weight of 3400 (¶00014). It therefore would have been obvious to use the claimed amount of a PEGDA having the required molecular weight in view of the teachings of Martinez.
Regarding claim 13: As noted above, the prior art teaches the use of a bioink wherein the thickener is polyethylene oxide.
Martinez is silent regarding bonding between the two polymers; however, it is reasonably expected that the primary and secondary networks are bonded in the prior art product.
“[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency under 35 U.S.C. 102, on prima facie obviousness under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same…" as that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (MPEP § 2112).
The prior art teaches a bioink that comprises the same components- i.e., polyethylene oxide and crosslinkable polyethylene glycol- as the claimed invention, which is then printed and crosslinked to form a final product. Note that the instant specification does not disclose any special steps and/or conditions required to obtain the claimed bonding; rather, the claimed invention is made by printing and curing a system comprising the two polymer components. As the prior art therefore teaches a crosslinked network comprising the same components and prepared via the same process as the claimed invention, it is reasonably expected that the polyethylene oxide and the polyethylene glycol become bonded to one another in the prior art product. The burden is therefore shifted to the applicant to provide evidence the required bonding would not be present in the crosslinked product disclosed by Martinez (for claim 1).
Claim(s) 1, 12, 13, and 17 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Stockman et al, US2019/0001018.
Stockman discloses a cured hydrogel made from a composition comprising a polyethyleneimine and a crosslinking agent which is a reactive polyethylene glycol (abstract, ¶0034).
Figure 38 of Stockman discloses examples of compositions used to make said cured hydrogel. Note the fifth embodiment reported in the Figure, which discloses a composition comprising a polyethylene imine having a molecular weight of 2000 (PEI2000), corresponding to the claimed primary polymer network (for claim 1), and a reactive polyethylene glycol (PEG3400-(SMB)2), corresponding to the claimed secondary polymer network (for claim 1).
Regarding the requirement that the primary and secondary networks are bonded to one another: Stockman teaches that the polyethyleneimine reacts with the functional groups of the polyethylene glycol (0034)-i.e., the two polymers become bonded to one another, corresponding to the claimed requirement of an interpenetrating network (for claim 1) wherein the first and second polymers are bonded to one another (for claim 1).
Regarding claims 12 and 13: As noted earlier in this Action, the phrase “one or more of” as recited in claim 12 only requires that one of the recited components be present in the recited amount. The fifth embodiment listed in the Table of Figure 38 is reported to contain 15 wt% of the crosslinking agent, and to have a ratio of polyethylene glycol : polyethyleneimine (w/w) of 15:1. Based on these numbers, one of ordinary skill in the art can calculate that the prior art composition comprises 1 wt% polyethyleneimine, corresponding to the claimed polymer (for claims 12, 13, 17).
Regarding the limitation of printing a bioink: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process"; see In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (MPEP § 2113(I)).
The prior art does not specifically refer to the prior art composition as a bioink; however, as discussed above, Stockman discloses the production of a composition that comprises the same components and has the same structure of a cured system wherein two polymers are bonded to one another as the claimed invention. As the prior art cured hydrogel appears to be the same as the claimed invention, the burden is shifted to applicant to provide evidence demonstrating that the recited process step results in an unobvious difference between the claimed invention and the prior art hydrogel (for claim 1).
Claim Rejections - 35 USC § 103
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Stockman et al, US2019/0001018.
As discussed earlier in this Action, Stockman discloses a cured hydrogel made from a composition comprising a polyethyleneimine (for claim 16) and a crosslinking agent which may be a reactive polyethylene glycol (abstract, ¶0034).
Regarding the claimed molecular weight: Said polyethyleneimine has a molecular weight in the range of 400 to 2,000,000 g/mol (0080), overlapping the claimed range (for claim 16).
Stockman does not specifically point to the production of a composition wherein the polyethyleneimine has a molecular weight of 25000 to 75000.
As noted above, the prior art range for the molecular weight of polyethyleneimine overlaps the claimed range. Barring a showing of evidence demonstrating unexpected results, it therefore would have been obvious to one of ordinary skill in the art to prepare the composition of Stockman using a polyethyleneimine having the required molecular weight; see In re Wertheim, In re Woodruff, and In re Peterson cited earlier in this Action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY S LENIHAN whose telephone number is (571)270-5452. The examiner can normally be reached Mon.-Fri. 5:30-2:00PM.
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/JEFFREY S LENIHAN/Primary Examiner, Art Unit 1765
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