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 .
Status of the claims
Claims 1-3, 5-6, and 17-18 are pending and under exam. Claims 19-24 are withdrawn due to being directed to nonelected invention. Claims 7-14 and 16 are cancelled.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/22/2025 has been entered.
WITHDRAWN REJECTIONS
Claim Rejections - 35 USC § 102
Claims 1, 3-6, 15 and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chu et al (hereinafter “Chu;” See PTO-892) further as evidenced by Jantzie et al (J Cereb Blood Flow Metab. 2005 Mar; hereinafter “Jantzie;” See PTO-892).
The rejections are withdrawn following claim amendment to cancel doxycycline.
Claim Rejections - 35 USC § 103
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Chu et al (hereinafter “Chu;” See PTO-892) in view of Hawkins et al (Ann Am Thorac Soc. 2015 Mar; hereinafter “Hawkins;” See PTO-892) further as evidenced by Jantzie et al (J Cereb Blood Flow Metab. 2005 Mar; hereinafter “Jantzie;” See PTO-892).
The rejections are withdrawn following claim amendment to cancel doxycycline.
NEW REJECTIONS/OBJECTIONS
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show colors as described in the specification. Reference is made to blue and red arrows (See Spec, [0021]) describing vehicle (blue line), Y-27632 (red line), Doxycycline 1 μg/mL (green line), or Doxycycline plus Y-27632, and other color references throughout the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be clearly shown in the drawing. MPEP § 608.02(d). 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. The replacement sheet(s) should be labeled "Replacement Sheet" in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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. Color photographs and color drawings are acceptable only for examination purposes. Therefore the drawings and specification must be amended to make the referenced points in the figures clearly distinguishable as black and white images.
Specification
The specification is objected to because of reference to colored referenced points within the drawings, see above. The specification must be amended to clearly reference the same figures without use of color identifiers, and to be in accordance with the changes in the drawings. Correction is required. See MPEP § 608.01(b).
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.
Claim 5 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Claims 5 and 18 contain the trademark/trade name Matrigel. 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. In the present case, the trademark/trade name is used to identify/describe coating on a tissue culture plate or a type of hydrogel and, accordingly, the identification/description is indefinite.
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.
Claim 1-3, 5-6, and 17-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
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.
Regarding claim 1: The claim required differentiation into definitive endoderm using Activin A and one of the agents selected from doxycycline, Gentamicin, minocycline, demeclocycline, methacycline, KB-R7943, or Ruthenium Red. It is however noted that the specification did not teach production of definitive endoderm from any and all iPS using each of the recited agents. For example, the specification explicitly stated that “[i]n addition KB-R7943 and Ruthenium Red also showed responses at specific doses in one cell line (AG02261) but not another cell line (AS7192).” (See specification [0018]). Further tetracycline derivatives Minocycline, Methacycline and Demeclocycline were tested on AG02261 and AS7192 cell lines. Figure 9A lower graph showed that the relative cell number at day 7 normalized to day 0 was below 1 in all the tested tetracycline derivatives across the concentrations tested, indicating that these cells died in the time period tested. As such this showed that the compounds were detrimental to the cell health of this strain. It is recognized that the benefit of the invention is specific only to certain strains of iPSCs.
It is additionally pointed out that the specification did not show production of definitive endoderm using Activin A and each of the claimed antibiotics or agents. Rather, the specification merely showed that each of the claimed antibiotics, at a specific concentration, increased survival of iPScs, probably by inhibition of proapoptotic pathways. (See Figure 9 and Example 4, for example). As such the full scope of the claim is not disclosed in the specification. Claims 4-6, 15 and 17-18 inherit the deficiency due to their dependence.
Claim 3 requires the inhibitors of caspase 3 cleavage. However, the specification did not teach a representative number of caspase 3 inhibitors. The specification at [0010], [0024] and [0058] taught doxycycline to be an inhibitor of caspase 3 cleavage. However, the specification provides no other caspase 3 inhibitor, nor does it provide any common discernable structural features that constitutes a caspase 3 inhibitors. As such the single example does not constitute a representative number of species which is required in order to claim the entire genus of caspase 3 inhibitors. As there is no sufficient disclosure of all caspase 3 inhibitors and the fact that there is no disclosure of relevant, identifying characteristics, such as structure or other physical or chemical properties, or functional characteristics, beyond disclosure of the generic action (caspase 3 inhibition), sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119F. 3d. at 1568, 43 USPQ2d at 1406. See MPEP § 2163.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAGAMYA VIJAYARAGHAVAN whose telephone number is (703)756-5934. The examiner can normally be reached 9:00a-5:00p.
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/JAGAMYA NMN VIJAYARAGHAVAN/Examiner, Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633