DETAILED ACTION
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 .
Election/Restrictions
Applicant's election without traverse of invention group 1, drawn to a medium composition for culturing porcine pluripotent stem cells, claims 1-14 in the reply filed on 07/22/2026 is acknowledged.
Claims 15-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species/invention.
Claim status
Claims 1-18 are pending.
Claims 15-18 are withdrawn.
Claims 1-14 are under examination.
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.
Claim 5 contains 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 culture media/ matrix and, accordingly, the identification/description is indefinite.
Claim 6 also recite the trade name Matrigel ® to identify/describe culture media/matrix and also depend on claim 5 which recite a tradename; accordingly, the description is indefinite. 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.
Claim 11 recite “stemness/pluripotency”, it is not clear if “/” is suggestive of whether the terms are interchangeable or different. Therefore, the claim is indefinite for failing to distinctly point out the subject matter.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 is dependent on claim 5. Claim 5 recites culturing cells in a culture vessel coated with extracellular matrix (ECM) or Matrigel ®. However, claim 6 lists poly-L-lysine as one of the culture vessel coating materials which fails to further limit the limitations of claim 5, as it is not a component of extracellular matrix or Matrigel ®.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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- 6, 9-14 are rejected under 35 U.S.C. 102(2) as being anticipated by Zhang et al., WO2015054526 A2.
Regarding claim 1, Zhang teaches a method of culturing isolated embryonic stem cells (ESCs) from a mammal in the presence of inhibitor of TGF-β/ BMP (claim 1), which is LDN-193189 (claim 16), wherein the said mammal is a pig (claim 9).
Regarding claim 2 and 14, Zhang teaches suitable culturing media to culture pig embryonic stem cells, in one embodiment, wherein the LDN193189 concentration is about 50nM (line 9, page 19)
Regarding claim 3, Zhang teaches culturing ESCs from a mammal (claim 1), wherein the said mammal is a pig (claim 9).
Regarding claim 4, Zhang teaches culturing the isolated ESCs in feeder free medium (claim 1 a), where in the isolated ESCs are from a pig (claim 9).
Regarding claim 5 and 6, Zhang teaches growing mammalian ESCs in feeder cell-free culture (claim1), wherein the mammal is a pig (claim 9), and the culture vessel is coated with Matrigel ®(claim 25).
Regarding claim 9-11, Zhang teaches the requisite composition of the culture medium, as claimed in claim 1 for culturing porcine pluripotent stem cells. Therefore, promoting proliferation and inhibiting apoptosis as claimed in claim 9, increasing number of stem cells and the size of the colonies as claimed in claim 10, enhanced stemness/pluripotency as claimed in claim 11 must be inherent to the claimed composition.
Regarding claim 12, Zhang teaches ESC culture medium composition containing 1.8 % of bovine serum albumin or equivalent (line 12, page 18, examples of suitable cell culture media).
Regarding claim 13, Zhang teaches culturing ESCs in the presence of one or more inhibitors of TGF-β/BMP signaling (claim 1), wherein inhibitors of TGF-β/BMP signaling consist of LDN193189 (claim 16). Therefore, Zhang teaches the requisite composition as instantly claimed.
Therefore, the reference 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1, 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al., WO2015054526 A2 and Liu et al., US20220145264A1, as evidenced by Zhi et al., 2022 and Nickle et al., 2024.
Regarding claim 1, Zhang teaches a method of culturing isolated embryonic stem cells (ESCs) from a mammal in the presence of inhibitor of TGF-β/ BMP (claim 1), where in the said mammal is a pig (claim 9), and the inhibitor of TGF-β/ BMP is LDN-193189 (claim16).
Regarding claim 7, Zhang teaches including the small molecule IWR-1, an inhibitor of Wnt signaling in their culture media for culturing ESCs (claim 13).
Teachings of Zhang are relied on above.
Zhang does not teach culturing porcine pluripotent stem cells in medium further comprising FGF2, activin A, CHIR99021.
However, before the effective filling date of the claimed invention, culturing porcine pluripotent stem cells in medium comprising FGF2, activin A, CHIR99021 was known in the art.
Liu teaches culturing porcine pluripotent stem cells in media containing bFGF, activin A, CHIR99021, as well as LDN193189 (paragraph 0283, 6.4 screening for the porcine EPSC culture conditions, page 18). IWR-1, bFGF, activin A, CHIR99021 promote self-renewal, and pluripotency in porcine stem cells, as evidenced by Zhi. FGF-2 and bFGF are the same protein as evidenced by Nickle.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to combine the above-mentioned teachings of Zhang and Liu to culture porcine pluripotent cells in media containing IWR-1, FGF2, activin A, CHIR99021. One of ordinary skill in the art would have been motivated to combine the teachings of Zhang and Liu in order to include the aforementioned small molecules and factors in the culture media to promote self-renewal, and pluripotency in porcine pluripotent cells. There would be a reasonable expectation of success to combine the teachings of Zhang and Liu because they teach invitro methods of culturing porcine pluripotent stem cells using LDN193189.
Regarding claim 8, Liu teaches culturing porcine pluripotent stem cells in culture media containing 10 ng/ml bFGF, 3 µM CHIR99021 (paragraph 0283, 6.4 screening for the porcine EPSC culture conditions), 2.5 -4.5 µM IWR-1 and 10 -50 ng/ml activin (claim 22).
Therefore, the claimed invention is prima facie obvious
Conclusion.
No claim is allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HASHANTHI ABEYRATNE-PERERA whose telephone number is (571)272-6562. The examiner can normally be reached Monday-Friday 7:30 am- 5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HASHANTHI KOMITIGE ABEYRATNE-PERERA/Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632
Prosecution Insights