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
This Office Action is in response to the Applicant’s reply received 5/6/26. Claims 1, 2, 4-9, 13-18, and 21-26 are pending. Claims 1, 2, 4-9, 15-18 and 21-26 are withdrawn. Claims 13 and 14 are considered on the merits.
Response to Election/Restriction Requirement
Applicant's response, with traverse, to the Restriction/Election requirement filed on 2/19/26 is acknowledged. The applicant elected Group IV which includes claims 13 and 14.
The Applicant argues that no undue burden would exist to search claims 15-18 which require the cells of claims 14. This argument relies on M.P.E.P. §802.02. Chapter 800, however, is limited to a discussion of the subject of restriction and double patenting under Title 35 of the United States Code and Title 37 of the Code of Federal Regulations as it relates to national applications filed under 35 U.S.C. 111(a). The discussion of unity of invention under the Patent Cooperation Treaty Articles and Rules as it is applied as an International Searching Authority, International Preliminary Examining Authority, and in applications entering the National Stage under 35 U.S.C. 371 as a Designated or Elected Office in the U.S. Patent and Trademark Office is covered in M.P.E.P. §1850 and is dictated by PCT Rules 13.1 and 13.2. See M.P.E.P. §801. Burden is not a consideration in a finding of lack of inventive unity; rather, according to M.P.E.P. §1850, the only consideration is whether the inventions share a special technical feature.
However it is noted that if claim 14 is found allowable, then all claims that include all the allowable limitations of 14 will likely be rejoined at time of allowance.
Therefore, the Restriction/Election requirement is therefore made FINAL and the elected species and the claims they include will now be examined on the merits.
Claim Interpretation
Claim 13 has a method step of culturing PSCs with an appropriate amount of BMP4 and Activin-A to produce aSHF cells with the claimed surface markers. The Specification never defines “an appropriate amount” so this reads on broad concentration ranges of each compound. The resulting aSHF cells read as an intended result of the method steps. MPEP 2111.04 state:
a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’"
Therefore these limitations are not afforded significant patentable weight and art reading on the method steps of the claim will also read on the intended results since the same steps should obviously yield the same results. However if these results are an unexpected improvement, then this should be pointed out by the Applicant and the claims made commensurate in scope with the results shown. Applicant is encouraged to contact the Examiner if any questions about this arise.
35 U.S.C. 101 REJECTION BASED ON JUDICIAL EXCEPTIONS
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 14 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim(s) 14 is/are directed to aSHF cells that appear to occur in nature. The Applicant’s Specification teaches aSHF cells occur naturally during cardiac development (Specification, Summary paragraph 1). Francou et al. (in IDS 3/21/24, NPL #34) and Miyamoto et al. also identify these cells as naturally differentiated cells in cardiac development (Francou, Fig. 1 and Miyamoto Abstract 2nd paragraph). While neither expressly teach the markers limited in claim 14 for these cells, these appear to be the natural properties of the cells since the differentiation of these cells appear to be in vivo exposure to BMP4 and Activin-A (Miyamoto, pg. 2, 2nd paragraph). Therefore it appears the aSHF cells in the body are inherently the same as those of claim 14 since they a) carry the same name, b) are identified during cardiac development, and c) and induced by the same physiological process which exposes their progenitor cells to BMP4 and Activin A. The Applicant can overcome this rejection by showing their process produces cells which are significantly different from their natural counterparts, or the aSHF cells are significantly different than those found naturally in the wall of the pericardium.
Claim Rejections - 35 USC § 102/103
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.
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.
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 102(a)(1) or under 35 U.S.C. 103 as being anticipated by or obvious over Lee et al. (Cell Stem Cell 2017, in IDS 3/21/24).
As detailed below, Lee et al. teach a product that appears substantially identical in structure to the claimed composition but does not explicitly state all the functional limitations such as the pattern of markers listed in claim 13. Therefore a dual rejection under 102/103 is made since the composition of Lee et al. either inherently meets the claims (M.P.E.P 2112 III and V) or is prima facie obvious since the compositions are structurally similar and share a similar utility and therefore are expected to have similar properties (MPEP 2144.09).
Fig 1A of Lee et al. teach culturing human pluripotent stem cells (hPSCs) in the presence of BMP4 and Activin A for 1-3 days to produce cardiac mesoderm cells. The amount of BMP4 ranges from 10-1 ng/ml while Activin A ranges from 0-10 ng/ml (Fig. 2B and C) including 1 ng/mL (Fig. S7A and F). They expressly use a ratio of 3ng/mL BMP4 to 2ng/mL Activin-A (Fig. 2E, 3B, and 5H-J, noted as 3B/2A) or 4ng/mL BMP4 to 1ng/mL Activin A(Fig. S7A, noted as 4B/1A). 3B/2A are close to the conditions used in to produce the claimed cells in Fig. 14A and 14C (3B/1A) and Fig. 1E-G (3B/1.5A). Therefore it appears the 3B/2A conditions are so close to the amounts used in the Specification to produce the claimed cells that the cells produced by Lee et al. are either obvious or inherently the same since the same steps should produce the same results.
Therefore the invention as a whole would have either been inherently anticipated or prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially 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 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 13 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5-8, 36 and 37, of copending Application No. 15/550572. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to culturing pluripotent stem cells in media with BMP4 and activin-A to generate cardiovascular mesoderm cells.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 13 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12, 25, 29 and 34 of copending Application No. 17/922731. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to culturing pluripotent stem cells in a mesoderm induction medium comprising BMP4 and activin-A to generate cardiovascular mesoderm cells.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 13 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 10, 11-19 of copending Application No. 18993925. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to culturing pluripotent stem cells (e.g. cardiac progenitor cells) in a medium comprising BMP4 and activin-A at a concentration ratio of 3ng/ml BMP4 and 2 ng/ml actavin-A to generate cardiovascular mesoderm cells.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 13 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10077428. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to culturing pluripotent stem cells in embryoid bodies in a medium comprising BMP4 and activin-A to obtain human cardiovascular progenitor cells
Claims 13 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 6 of U.S. Patent No. 12460183. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to culturing pluripotent stem cells in a medium comprising BMP4 and activin-A to obtain human cardiovascular progenitor cells
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
Prosecution Insights