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 .
Claim Status
Claims 1-18 are currently pending in this application.
Election/Restrictions
Applicant’s election of Group I, claims 1-8 and 18, in the reply filed on Dec. 11, 2025 is acknowledged. Claims 9-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). Applicant’s election of the peptide species SEQ ID NO: 1 is acknowledged. Claims 1-8 and 18 have been considered on the merits.
Claim Interpretation
Claim 1 is interpreted as a product-by-process due to the phrases “is formed by mixing and extruding the cell solution and the self-assembling peptide solution together” and “the bioink is extruded from the mixer after mixing.”
In claim 1, the phrase “a self-assembling peptide” is interpreted as requiring at least a singular such peptide, i.e., a single molecule, and when a plurality of such peptides are present there is no implied limitation that any self-assembly need be present.
In claim 1, the phrase “the bioink is extruded from the mixer after mixing” is interpreted as requiring the “mixing and extruding of the cell solution and the self-assembling peptide solution together” as referring to the claimed bioink, i.e., “the bioink that is extruded from the mixer after mixing.”
In claim 7, the term “immersion solution” is interpreted as a matter of logic as requiring a preceding step of extruding the bioink before the bioink is made to further comprise the immersion solution. While it is improper to read a specific order of steps into method claims, in this case as a matter of logic the interpretation is limited herein, however applicant is invited to furnish evidence to the contrary.
In claim 18, the phrase “peptides having” is interpreted to mean “consisting of.”
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is: a means which “urges the bioink to be extruded” in claim 6.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(a) - Written Description and Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3 and 5-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, and 35 U.S.C. 112(b) as failing to comply with the written description and enablement requirements. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention as a whole is not adequately described if the claims require essential or critical elements that are not adequately described in the specification and that is not conventional in the art as of applicant’s effective filing date. Possession may be shown by actual reduction to practice, clear depiction of the invention in a detailed drawing, or by describing the invention with sufficient relevant identifying characteristics such that a person skilled in the art would recognize that the inventor had possession of the claimed invention. Pfaff v. Wells Electronics, Inc., 48 USPQ2d 1641,1646 (1998).
In making a determination of whether the application complies with the written description requirement under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant is claiming and what Applicant has possession of.
The claims are directed to bioink compositions comprising any self-assembling peptide. The claims are broad in that the term “self-assembling” peptide is only defined functionally and potentially encompasses any peptide only limited by the knowledge of the skilled artisan in view of the prior art.
Assuming a conservative peptide size of 20 amino acid residues, there are potentially over 1 x 1026 structures to consider.
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described. In the instant case, the specification clearly provides 23 species of self-assembling peptides (Table 1, SEQ ID NOs: 1-23). However the instant application fails to describe any structural functional nexus between the peptide structure and the self-assembling behavior. Thus, these limited species are not representative of the potentially trillions of peptide species encompassed by claim 1.
The skilled artisan could not rely upon the disclosure in the specification such that the specification would sufficiently describe that Applicant was in possession of the full scope of functionally defined “self-assembling” peptides without structural limit, e.g., due to a functional nexus to a structural feature(s). The dependent claims are included in the basis of the rejection because they do not correct the primary deficiencies of the independent claim.
Lack of Enablement
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Amgen, Inc., v. Sanofi (U.S. Supreme Court, No. 21-757 (2023))
“Amgen seeks to monopolize an entire class of things defined by their function”.
“The record reflects that this class of antibodies does not include just the 26 that Amgen has described by their amino acid sequence, but a “vast” number of additional antibodies that it has not.” “They leave a scientist forced to engage in painstaking experimentation to see what works. 159 U.S., at 475. This is not enablement. More nearly, it is “a hunting license”. Brenner v. Manson, 383 U.S. 519, 536 (1966).
“Amgen has failed to enable all that it has claimed, even allowing for a reasonable degree of experimentation”.
While the “roadmap” would produce functional combinations, it would not enable others to make and use the functional combinations; it would instead leave them to “random trial-and-error discovery”.
“Amgen offers persons skilled in the art little more than advice to engage in “trial and error”.
The instant case is similar to the Amgen case as outlined above in the written description section. Claims 1-3 and 5-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the full genus of self-assembling peptides encompassed by claim 1.
Extensive experimentation would be required to determine from among 1026 peptide structures which ones exhibit self-assembling activity. It is unpredictable because there is not necessarily any shared common feature that ensures self-assembling behavior among all peptide sequences. Given the few (23) working examples, the limited guidance provided in the specification, and the broad scope of the claims, undue and unreasonable experimentation would have been required for one skilled in the art to make/use the claimed invention.
Claim Rejections - 35 USC § 112(b)
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 1-8 and 18 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the term “the mixer”, which lacks sufficient antecedent basis. Claims 2-8 and 18 are included in this rejection for depending from indefinite claim 1.
Claim 1 recites the process step of extruding the bioink “from the mixer after mixing.” Claim 1 is rejected under 35 U.S.C. 112(b) as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: a control valve and nozzle opening that permits only mixed bioink to be extruded. Claims 2-8 and 18 are included in this rejection for depending from indefinite claim 1.
Claim 4 is indefinite for unnecessarily incorporating Table 1 by reference. See MPEP 2173.05(s).
Claim 5 recites a “thickening agent”, which is neither defined by the claims nor the instant application and thus is incoherent and ambiguous as the self-assembling peptide may function as a thickening agent due to its self-assembling activity. Under a broadest reasonable interpretation, a thickening agent encompasses anything that increases the viscosity of the bioink.
Claim 6 recites the term “urges” regarding an action/activity of bioink extrusion from a mixer due to the introduction of one or more of the bioink’s components to the mixer. Claim 6 is rejected under 35 U.S.C. 112(b) as interpreted under 35 U.S.C. 112(f) because the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function of urging extrusion. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 6 is also rejected under 35 U.S.C. 112(b) as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: the relationship between introducing the bioink component(s) to the mixer and the extruding of the bioink from the mixer as well as the control valve and nozzle that permits only mixed bioink to be extruded as noted above for claim 1.
Claim 7 recites the relative term “partially”, which is indefinite because neither the claim nor the specification provides a standard or means for determining the requisite level of “partially” or “at least partially” to inform the skilled artisan of the metes and bounds of this limitation. Furthermore, it is incoherent and ambiguous as to how a bioink can both comprise an immersion solution and by partially immersed in said solution.
Claim 8 recites the term “consolidation” solution which is indefinite because neither the claims, instant specification or prior art provides a definition. From the claim language the term “consolidation solution” is merely functionally defined with an intended use “to adjust pH,” presumably of the bioink and/or its components prior to bioink formation during mixing. For purposes of examination, the term consolidation solution is interpreted as encompassing any aqueous solution comprising protons, hydroxide anions, other cations/anions, and/or other buffering agents, e.g., HEPES, Tris, citrate.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 5-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hauser (US2020/0148720A1; IDS ref.).
Regarding claim 1, Hauser discloses a bioink and method of making it comprising extruding a bioink from a 3D bioprinter ([0144], [0005]) comprising a self-assembling peptide solution ([0006], e.g., one of SEQ ID NOs: 1-128) and comprising living cells and medium in a second solution, e.g., fibroblasts ([0125]; [0104]), whereby mixing occurs in a mixer (nozzle) due to pressure forcing the two solutions together ([0144]).
Regarding claim 5, Hauser does not teach adding a thickening agent or crosslinker as a requirement for all embodiments, instead relying on the inherent and virtually instantaneous gelation activity of the peptide to form a hydrogel for cell culture ([0144]) and thus discloses wherein there is no thickening agent present.
Regarding claim 6, Hauser discloses wherein the extrusion occurs due to a pumping force(s), e.g., from a syringe pump(s), flowing the peptide solution and/or cell solution.
Regarding claim 7, Hauser discloses wherein the printed bioink composition is submerged (i.e., immersed) in a wash solution and then a cell culture medium solution ([0144]).
Regarding claim 8, Hauser discloses wherein three syringes mix the peptide solution, the cell solution, and a third solution comprising the buffer 10X PBS capable of adjusting the pH prior to bioink extrusion via a nozzle opening ([0144]).
Thus, Hauser anticipates the claimed invention.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hauser (US202000148720A1; IDS ref.) in view of Burgess (Burgess, “Peptide Hydrogel for Advanced 3D Cell Culture”. PhD Thesis (2018); IDS ref.).
The claims are interpreted as set forth in a previous section. Also as set forth above, Hauser anticipates claims 1 and 5-8, and thus renders obvious the subject matter of claims 1 and 5-8.
Regarding claims 2-3, Hauser does not expressly teach any specific ratio of mixing the peptide and cell solutions.
However Burgess teaches self-assembling hydrogels for cell culture made using a ratio of the self-assembling peptide solution to cell solution that is between 6 to 1 and 20 to 1 by volume (a 10 µL aliquot of the cell stock solution was mixed into the hydrogel producing a gel of 100 µL, wherein the peptide (F8) is similar to instant SEQ ID NO: 18 (pg. 67, 2nd para., to pg. 68, 1st para.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective time of filing to perform the method of bioink 3D printing taught by Hauser specifically using the self-assembling peptide and cell solution 10:1 ratio taught by Burgess. One of ordinary skill in the art would be motivated by Burgess already validating this specific ratio for the solutions and peptides tested. Note, an overlapping range between the prior art and a claim provides a prima facie case of obviousness (see MPEP 2144.05). Therefore, the claimed invention as a whole is prima facie obvious to a person of ordinary skill before the earliest effective filing date of the claimed invention in the absence of evidence to the contrary.
Claims 1, 4-8, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hauser (US202000148720A1; IDS ref.) in view of Gelain (Gelain et al., PLoS One 1: e119 (2006)).
Regarding claims 4 and 18, Hauser does not wherein the self-assembling peptide is any one of instant SEQ ID NOs: 1-23, such as SEQ ID NO: 1.
However Gelain teaches the self-assembling peptide RADA16 consisting of instant SEQ ID NO: 1 as shown below (Abstract), or functionalized variants thereof (Fig. 1). Gelain teaches using RADA16 scaffolds for 3-D cell culture for a variety of cells, with advantages of custom-design and tunability as well as providing cell adhesion and mimicking Matrigel (Abstract).
Query Match 100.0%; Score 76; Length 16;
Best Local Similarity 100.0%;
Matches 16; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RADARADARADARADA 16
||||||||||||||||
Db 1 RADARADARADARADA 16
It would have been prima facie obvious to one of ordinary skill in the art before the effective time of filing to perform the method of bioink 3D printing taught by Hauser specifically using the self-assembling peptide RADA16 (instant SEQ ID NO: 1) taught by Gelain. One of ordinary skill in the art would be motivated by Gelain already validating conditions for this specific self-assembling peptide for use with neural stem cells with to provide cell adhesion during cell culture. Therefore, the claimed invention as a whole is prima facie obvious to a person of ordinary skill before the earliest effective filing date of the claimed invention in the absence of evidence to the contrary.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 4-5, 7-8 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 9, and 11 of copending Application No. 18/296168 (reference application) in view of Hauser (US202000148720A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because reference claim 1 teaches a bioink comprising a combination of a self-assembling peptide solution and a cell solution whereby a self-assembling peptide solution is extruded from some unnamed thing prior to mixing/combining in the cell solution to form the bioink (an object comprising living cells).
Although the reference claims do not expressly teach mixing the two solutions in a mixer prior to extrusion, Hauser does ([0144]). Thus, it would be obvious to modify the reference claim method to change the order of mixing and extruding to arrive at the same final bioink as a product-by-process wherein the products have identical structural limitations and neither the instant claims nor the reference claims imply any unrecited limitation due to the process used to make the bioink. Regarding instant claims 4-5, 7-8 and 18, reference claims 2, 4-5, 9, and 11 teach the same limitations, including all of instant SEQ ID NOs: 1-23 and specifically instant SEQ ID NO: 1 alone. This is a provisional nonstatutory double patenting rejection because the reference application claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC J ROGERS whose telephone number is (571)272-8338. The examiner can normally be reached Monday - Friday 9:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached on (571) 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC J ROGERS/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638