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 .
DETAILED ACTION
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 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.
Election/Restrictions
Applicant’s election without traverse of Invention I, claims 1-12, in the reply filed on Dec. 1, 2025 is acknowledged.
Claims 1-19 remain pending in the current application, claims 13-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
The requirement for the restriction of Inventions I-IV is still deemed proper and is therefore made FINAL.
Claims 1-12 have been considered on the merits.
Status of the Claims
Claims 1-19 are currently pending.
Claims 13-19 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 1-12 have been considered on the merits.
Drawings
The disclosure is objected to because of the following informalities:
The drawings are objected to because of the following informalities: there is description of color in the Specification of Fig. 1 in 0036, Fig. 2 in 0037, Fig. 6 in 0041, Fig. 8 in 0043, and Fig. 9 in 0044, and the various colors cannot be distinguished from each other since the figures are in black and white. It is noted that in paragraph 0010 of the specification there is a statement that there is a least one drawing in color and that copies will be provided by the office upon request and payment of fee, but no color petition has been submitted and approved.
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.
Specification
The disclosure is objected to because of the following informalities: the use of trademarks.
The use of the terms: Triton™-X in 0049; GraphPad® Prisma v 8.1.2 in 0050; N2 B-27™ medium in 0052; and B-27™ medium in 0052, which are a trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
The disclosure is objected to because of the following informalities:
Claim 2 at line 2, the terms “peptide having” are misspelled “peptideaving”.
Claim 2 is objected to in the recitation of “phenylalanine, hydrophobic amino acid phenylalanine” in lines 9-10, and in the interest of improving claim form, it is suggested that the recited phrase be amended to recite “phenylalanine” or be amended as follows: “phenylalanine
Claim 2 is objected to for missing either a comma or semi-colon after “XBmAn” in line 3.
Claim 2 is objected to for missing a comma after “phenylalanine” in line 12.
Claim 2 is objected to for having a period instead of a comma in line 13 following the phrase “0-3”. A claim should only contain one period. Please see MPEP 608.01(m).
Appropriate correction is appreciated.
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 2, 6 and 7 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.
Claim 2 recites “comprised of a peptidomimetic amino acid that is the aliphatic counterpart of the aromatic amino acid, such as cyclohexylalanine, which is the counterpart of amino acid phenylalanine”. The metes and bounds of the phrase “such as” is unclear because it raises confusion as to whether the optional language was intended to describe the peptidomimetic amino acid that is the aliphatic counterpart of the aromatic amino acid or whether the peptidomimetic amino acid is required to be cyclohexylalanine. Appropriate clarification is required. Moreover, the MPEP 2111.04 states that “a claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”. Therefore, in this case for the purpose of compact prosecution, the peptidomimetic amino acid of “cyclohexylalanine” will be interpreted as the optional amino acid and therefore is/are non-limiting or not required.
In claim 6, line 2, the phrase "peptide hydrogel construct" lacks sufficient antecedent basis and renders the claim and its dependents indefinite. There is no antecedent basis in claim 1 from which claim 6 depends from for a peptide hydrogel construct, but instead a “ultrashort self-assembling peptide scaffold”.
Claim 7 depends from itself and, therefore, lacks antecedent basis for “The 3-dimensional neuronal tissue models of claim 7” and “the peptide scaffold”. For the sake of compact prosecution the claim will be interpreted to depend from claim 1.
Appropriate correction is appreciated.
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, 4 and 6-12 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Genove et al. (WO 2005/014615 A2).
With respect to claim 1, Genove teaches a 3D tissue model containing neurons and a scaffold comprising ultrashort self-assembling peptides (0098-0099, 00103 and 00105). Genove teaches self-assembling peptides that are 8 amino acids long or are ultrashort (Table 1). With respect to claim 4, Genove teaches the self-assembling peptides at a concentration of 5, 10, 15 and 20 mg/ml (0091). With respect to claim 6, Genove teaches a 3D tissue model where the encapsulated cells are at a density of 5 x106 cells/ml to 5 x 107 cell/ml (5,000 cells/µl to 50,000 cells/µl) (00102). With respect to claim 7, Genove teaches peptide structure supports the proliferation of the cells and neurite outgrowth (growth and branching of neurites) and teaches the structure can support of the growth of axons and other neuron processes (0041, 0060, 0075 and 00103). With respect to claim 8, Genove teaches the 3D tissue model where at least 90% of the cells are viable (00104).
Although Genove does not explicitly teach the 3-dimentional neuronal tissue model where the extracellular electrical activities are detectable using electrode-based detection methods and where the electrode-based detection method is a multielectrode array as recited in claim 9, Genove teaches the claimed 3-dimentional neuronal tissue model, therefore, the tissue model taught by Genove should inherently be capable of having its extracellular electrical activities be detected by electrode-based detection that is a multielectrode array as claimed.
Even though Genove does not explicitly teach the 3-dimentional neuronal tissue model as an in vitro drug testing platform as recited in claim 10, or as a tool for studying neurological disorders as recited in claim 11, Genove teaches the claimed 3-dimentional neuronal tissue model, and therefore, the tissue model taught by Genove should inherently be capable of use as an in vitro drug testing platform and as a tool for studying neurological disorders as claimed. Even though, Genove does not teach that their 3-dimentional neuronal tissue model can be used in the manner instantly claimed for an in vitro drug testing platform as recited in claim 10 or for a tool for studying neurological disorders as recited in claim 11, the preambles in both claims fail to limit the structure of the claimed invention and these statements are considered statements of purpose or intended use of the invention. “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. (MPEP 2111.02 Section II) In the instant case, the claim body describes a structurally complete invention in which the deletion of the preamble would not affect steps of the claimed invention.
With respect to claim 12, Genove teaches 3-dimentional neuronal tissue model for use to repair and regeneration of neural tissue (0061, 00213-00214). Even though, Genove does not explicitly teach the 3-dimentional neuronal tissue model as a surgical implant for cellular replacement therapies for neurodegenerative diseases, brain cancer, traumatic brain injuries or other neurological disorders as recited in claim 12, Genove teaches the claimed 3-dimentional neuronal tissue model, therefore, the tissue model taught by Genove should be capable for use as a surgical implant for cellular replacement therapies for neurodegenerative diseases, brain cancer, traumatic brain injuries or other neurological disorders as claimed. Furthermore, Genove teaches it can be used for neural tissue repair and regeneration. Additionally, the preamble in the claim fails to limit the structure of the claimed invention and is considered a statement of purpose or intended use of the invention. “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. (MPEP 2111.02 Section II) In the instant case, the claim body describes a structurally complete invention in which the deletion of the preamble would not affect steps of the claimed invention.
Therefore, the reference anticipates the claimed subject matter.
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 and 4-12 are rejected under 35 U.S.C. 103 as being unpatentable over Genove et al. (WO 2005/014615 A2).
With respect to claim 1, Genove teaches a 3D tissue model containing neurons and a scaffold comprising ultrashort self-assembling peptides (0098-0099, 00103 and 00105). Genove teaches self-assembling peptides that are 8 amino acids long or are ultrashort (Table 1). With respect to claim 4, Genove teaches the self-assembling peptides at a concentration of 5, 10, 15 and 20 mg/ml (0091). With respect to claim 6, Genove teaches a 3D tissue model where the encapsulated cells are at a density of 5 x106 cells/ml to 5 x 107 cell/ml (5,000 cells/µl to 50,000 cells/µl) (00102). With respect to claim 7, Genove teaches peptide structure supports the proliferation of the cells and neurite outgrowth (growth and branching of neurites) and teaches the structure can support of the growth of axons and other neuron processes (0041, 0060, 0075 and 00103). With respect to claim 8, Genove teaches the 3D tissue model where at least 90% of the cells are viable (00104).
Although Genove does not explicitly teach the 3-dimentional neuronal tissue model where the extracellular electrical activities are detectable using electrode-based detection methods and where the electrode-based detection method is a multielectrode array as recited in claim 9, Genove teaches the claimed 3-dimentional neuronal tissue model, therefore, the tissue model taught by Genove should inherently be capable of having its extracellular electrical activities be detected by electrode-based detection that is a multielectrode array as claimed.
Even though Genove does not explicitly teach the 3-dimentional neuronal tissue model as an in vitro drug testing platform as recited in claim 10, or as a tool for studying neurological disorders as recited in claim 11, Genove teaches the claimed 3-dimentional neuronal tissue model, and therefore, the tissue model taught by Genove should inherently be capable of use as an in vitro drug testing platform and as a tool for studying neurological disorders as claimed. Even though, Genove does not teach that their 3-dimentional neuronal tissue model can be used in the manner instantly claimed for an in vitro drug testing platform as recited in claim 10 or for a tool for studying neurological disorders as recited in claim 11, the preambles in both claims fail to limit the structure of the claimed invention and these statements are considered statements of purpose or intended use of the invention. “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. (MPEP 2111.02 Section II) In the instant case, the claim body describes a structurally complete invention in which the deletion of the preamble would not affect steps of the claimed invention.
With respect to claim 12, Genove teaches 3-dimentional neuronal tissue model for use to repair and regeneration of neural tissue (0061, 00213-00214). Even though, Genove does not explicitly teach the 3-dimentional neuronal tissue model as a surgical implant for cellular replacement therapies for neurodegenerative diseases, brain cancer, traumatic brain injuries or other neurological disorders as recited in claim 12, Genove teaches the claimed 3-dimentional neuronal tissue model, therefore, the tissue model taught by Genove should be capable for use as a surgical implant for cellular replacement therapies for neurodegenerative diseases, brain cancer, traumatic brain injuries or other neurological disorders as claimed. Furthermore, Genove teaches it can be used for neural tissue repair and regeneration. Additionally, the preamble in the claim fails to limit the structure of the claimed invention and is considered a statement of purpose or intended use of the invention. “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. (MPEP 2111.02 Section II) In the instant case, the claim body describes a structurally complete invention in which the deletion of the preamble would not affect steps of the claimed invention.
With respect to claim 5, Genove teaches the peptide scaffolds have a low elastic modulus in the range of 1-10 kPa (0093). Although Genove does not teach the exact ranges recited in claim 5 of at least 5 kPa, the range overlap significantly with the range taught. Furthermore, one of ordinary skill in the art would recognize that the rigidity of the scaffold is a result effective variable and that the rigidity of the scaffold would be matter of routine optimization as evidenced by Genove. Genove teaches a low elastic modulus allows for scaffold deformation due to cell contraction and may provide a means for cell-cell communication. Genove teaches that the scaffold stiffness can be controlled by a number of ways including changing the peptide sequence, concentration and length (0093).
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claim 2 is rejected under 35 U.S.C. 103(a) as being unpatentable over Genove (as applied to claims 1 and 4-12 above), and further in view of Tao et al. (Chemical Society Reviews, 2016).
The teachings of Genove can be found in the previous rejection above.
Genove does not teach the 3-dimentional neuronal tissue model where the ultrashort self-assembling peptide has the general formula of those recited in claim 2.
However, Tao teaches self-assembling individual or single amino acids and teaches scaffolds containing single amino acids that are K, D or S (A0B0X) (pg. 1 para. 1, pg. 5 Col. 1 last para. and Table 1). Tao teaches additional short self-assembling peptides (Table 1). Tao teaches that peptides composed of sequences shorter than five amino acids and single amino acids have lower synthesis costs and ease of modulation compared to larger biomacromolecules (pg. 1 para. 1). Additionally, Tao teaches the short peptides can be used for cell cultivation (pg. 1 para. 2 and Fig. 1).
At the time of the claimed invention, one of ordinary skill in the art would have been motivated to modify the teachings of Genove in such a way that the ultrashort self-assembling peptide is one of the claimed peptides for the purpose being able form a 3-dimensional neuronal tissue model, since single amino acids and other ultrashort peptides were known in the art as a scaffold for cells as taught by Tao. Furthermore, it would have been obvious to one skilled in the art to have further modified Genove such that the ultrashort self-assembling peptide is one of the claimed peptides, since scaffolds were known to be formed by single amino acids and many similar ultra-short peptides as taught by Tao. Such a modification merely involves the substitution of one known type of ultrashort self-assembling peptide for another for a scaffold containing cells. Furthermore, one of ordinary skill in the art would have been motivated to make such a modification of the 3D neuronal tissue model for the known benefits having lower synthesis costs and their ease of modulation compared to larger biomacromolecules as taught by Tao.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claim 3 is rejected under 35 U.S.C. 103(a) as being unpatentable over Genove (as applied to claims 1 and 4-12 above), and further in view of Hauser et al. (WO 2018/207036 A1).
The teachings of Genove can be found in the previous rejection above.
Genove does not teach the 3-dimentional neuronal tissue model where the ultrashort self-assembling peptide has the sequences of IIFK, IIZK, FFIK, IVFR, IVZR, or KIVAV as recited in claim 3.
However, Hauser teaches a 3-dimentional tissue model containing ultrashort self-assembling peptide scaffolds and cells (abstract, pg. 2 lines 15-18, pg. 18 lines 7-12 and 28-29, pg. 20 lines 12-14). Hauser teaches the hydrogel containing self-assembling peptides containing IVFR (SEQ ID NO: 33) and cells (pg. 5 and pg. 21 lines 11-15). Hauser teaches that the ultrashort peptides are useful for biological and biomedical applications and have the additional advantages that they are extremely easy and economical to synthesize (pg. 18 line 31 to pg. 19 line 2).
At the time of the claimed invention, one of ordinary skill in the art would have been motivated to modify the teachings of Genove in such a way that the ultrashort self-assembling peptide is one of the claimed peptides for the purpose being able form a 3-dimensional neuronal tissue model, since IVFR was known in the art as a scaffold for cells as taught by Hauser. Furthermore, it would have been obvious to one skilled in the art to have further modified Genove such that the ultrashort self-assembling peptide is one of the claimed peptides, since scaffolds were known to be formed by IVFR and many similar peptides as taught by Hauser. Such a modification merely involves the substitution of one known type of ultrashort self-assembling peptide for another for a scaffold containing cells. Furthermore, one of ordinary skill in the art would have been motivated to make such a modification of the 3D neuronal tissue model for the known benefits of the peptides being useful for biological and biomedical applications that they are extremely easy and economical to synthesize as taught by Hauser.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632