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 .
Claims 19-40 are pending and under consideration. Applicant has indicated some claims as withdrawn. There is no restriction requirement and all claims are being considered.
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 19-40 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 19 is unclear because it uses relative and vague terminology such as “enriched” and “have been depleted”. The claim is indefinite with regard to what is encompassed by “enriched” as there is no basis for comparison. When looking at a population of cells, one cannot determine if it is “enriched”. Likewise, there is no required level of depletion or comparison. Claim 19 does recite that the population is iPS-derived. This is a product by process type of limitation and is given weight only with regard to how that process affects the properties of the product. In the instant case, undifferentiated or partially differentiated cells could be present and alter the overall composition of the population. However, if these cells are removed, what remains is a population of RPE cells.
Claim interpretation-In its most broad sense, claim 19 is interpreted as a population of RPE cells.
Claim 20,21 and 29-31 are unclear because they depend from claim 19 or 20 and refer to the “starting cell population”. There is no starting cell population in claim 19 or 20. It is not likely the iPS cells are the starting population that is intended. Claim 20 reads more like a method claim where the “starting cells population” is a heterogeneous mixture of cells and non-RPE is removed. However, claims 19 and 20 are not method claims.
Claim 21 is also unclear because the added limitation reads as a method step describing an assay performed on the cells. It is not clear that this adds any further limitation to the population of RPE.
Claims 22,23,27 and 39 are unclear based on their dependency from claim 19.Claims 25,26,28,32-35,37-38,40 are unclear based on their dependency from claim 20.
Claim 24 and 36 are unclear because “essentially pure” is not defined by the specification. The term “essentially” is subjective and undefined. It is also no clear if this phrase is describing the RPE cells or the cell population.
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 19-31 and 34-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claim(s) recite(s) an enriched RPE cell preparation with a depleted level of CD56, CD24, and/or CD90-expressing cells, which fail to differ from a population of RPE cells in nature. This judicial exception is not integrated into a practical application because For example, if the claim is directed to an naturally occurring cell type with additional generic elements such purifying them, which does not add a meaningful limitation to the product because purifying is merely a nominal or token extra-solution component of the claim and is nothing more than an attempt to generally link the product of nature to a particular technological environment. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception purifying the cells, when considered separately and in combination, they do not add significantly more (also known as an “inventive concept”) to the exception. These additional limitations are well-understood, routine, conventional computer functions as recognized by the court decisions listed in MPEP § 2106.05(d)
The Office published the guidance document entitled 2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Eligibility Guidance), published December 16, 2014.
PNG
media_image1.png
635
566
media_image1.png
Greyscale
Step 2A has recently been revised to include two prongs (Federal Register / Vol. 84, No. 4 / Monday, January 7, 2019):
PNG
media_image2.png
447
453
media_image2.png
Greyscale
Analysis is as follows:
Step 1: The claim is directed to a composition of matter (skeletal muscle precursor cells).
Step 2A – Prong 1: Examiners evaluate whether the claim recites a judicial exception. The composition of matter (a cell) is directed to a natural phenomenon (Step 2A, prong 1, yes). The claim recites an enriched RPE cell preparation comprising RPE cells. MPEP §2106.04(b)(I) which shows that isolated DNA and cloned animals are considered natural phenomenon, for example.
Step 2A- Prong 2: Examiners evaluate whether the claim recites additional elements that integrate the exception into a practical application of that exception. This judicial exception is not integrated into a practical application because claims 19-31 and 34-40 do not recite additional elements that integrate the judicial exception into a practical application.
Finally, Step 2B the claim is evaluated as to whether it provides an inventive concept. With no additional elements, there is no inventive concept (Step 2B, No).
Markedly different characteristics can be expressed as the product' s structure, function, and/or other properties. In accordance with this analysis, a product that is purified or isolated, for example, will be eligible when there is a resultant change in characteristics sufficient to show a marked difference from the product' s naturally occurring counterpart. If the claim recites a nature-based product limitation that does not exhibit markedly different characteristics, the claim is directed to a ‘‘product of nature' ' exception (a law of nature or naturally occurring phenomenon), and the claim will require further analysis to determine eligibility based on whether additional elements add significantly more to the exception. It is concluded, here, that the claimed natural products are not markedly different from their natural counterparts as a result of an isolation or purification process.
Based on the guidance, The Supreme Court has identified a number of considerations for determining whether a claim with additional elements amounts to significantly more than the judicial exception itself. Limitations that may be enough to qualify as ‘‘significantly more' ' when recited in a claim with a judicial exception include: Improvements to another technology or technical field; improvements to the functioning of the computer itself; applying the judicial exception with, or by use of, a particular machine; effecting a transformation or reduction of a particular article to a different state or thing; adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application; or other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
Limitations that were found not to be enough to qualify as ‘‘significantly more' ' when recited in a claim with a judicial exception include: Adding the words ‘‘apply it' ' (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer; simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry; adding insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea; or generally linking the use of the judicial exception to a particular technological environment or field of use.
In the instant case, the limitations of the claims do not impose limits on the claim scope such that they are not markedly different in structure from a naturally occurring product. In particular, the claims are directed to an enriched cell preparation comprising RPE cells.
Accordingly, as a whole, based upon an analysis with respect to the claim as a whole, claim(s) 19-31 and 34-40 do not recite something significantly different than a judicial exception. Thus, based upon this analysis, the claims are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter.
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.
Claim(s) 1-31 and 34-40 are rejected under 35 U.S.C. 102a1 as being anticipated by Davis (Stem Cell Research (2009) 2, 113–12) as evidenced by Sundberg (2009, Stem Cell Research, 2:113-124; IDS) and and Reinisalo (2012, Thesis:Studies on Retina-specific Gene expression, School of Pharmacy, Faculty of Health Sciences, University of Eastern Finland Kuopio )..
Claim 19 is interpreted as being drawn to an “enriched” population of RPE cells wherein CD56+, CD24+ and/or CD90+ cells have been “depleted”.
Davis teaches an RPE cell line which is essentially pure (claim 24,36), at least 95% and 99% pure (claims 22-23,34-35) and “enriched” (all claims). An RPE cell line would lack CD56+, CD24+ and/or CD90+ cells (claim 28-31) because these genes are not expressed in RPE , as evidenced by Sundberg, who teaches that these are markers of undifferentiated pluripotent cells or partially differentiated cells of the neural lineage. Claim 21 is met by any pure population of RPE cells as it recites a limitation to an assessment of the population that does not change the population. It is the population being claimed, not a method of obtaining cells. Claims 25-26 recite how cells were removed from the population but because these cells are not part of the population, the cells of Davis would meet the claimed enriched population of RPE cells. The cells are not genetically modified (claim 27,37-38). With regard to claims 39 and 40, PMEL17 and TYRP1 are proteins inherently present in RPE cells and are required for pigmentation as evidenced by Reinisalo.
Claim(s) 19-31 and 34-40 are rejected under 35 U.S.C. 102a1 as being anticipated by Pennington (STEM CELLS TRANSLATIONAL MEDICINE 2015;4:165–177) as evidenced by Sundberg (2009, Stem Cell Research, 2:113-124; IDS).
Claim 19 is drawn to an enriched population of RPE cells derived from iPSCs wherein CD56+, CD24+, and/or CD90+ cells have been depleted.
With regard to claims 19 and 20, Pennington teaches derivation of RPE from ESCs and iPSCs (pluripotent stem cells; page 165, 170). RPE cells were manually isolated (enriched) and cultured to derive an essential pure population of RPE (claim 24,36), at least 95% and 99% pure (claims 22-23,34-35). A clonal culture of RPE would lack CD56+, CD24+ and/or CD90+ cells (claim 28-31) because these genes are not expressed in RPE , as evidenced by Sundberg, who teaches that these are markers of undifferentiated pluripotent cells or partially differentiated cells of the neural lineage. With regard to claims 39-40. Pennington taught, “At passage 2 day 28, H9 hESC-RPE derived on Synthemax II-SC expressed Tyrp1 and PMEL17” and “All cultures were more than 95% positive for the protein PMEL17…” (page 172 and Figure 3). Pennington does not comment on the number of cells expressing the RPE marker TYRP1. However, Pennington does teach that it is expressed, the cells are a pure population, TYRP1 is a marker of those cells and is co-detected as a marker of those cells with PMEL17, which is present in over 95% of the cells. Claim 21 is met by any pure population of RPE cells as it recites a limitation to an assessment of the population that does not change the population. It is the population being claimed, not a method of obtaining cells. Claims 25-26 recite how cells were removed from the population but because these cells are not part of the population, the cells of Davis would meet the claimed enriched population of RPE cells. The cells are not genetically modified (claim 27,37-38).
Claim(s) 1-40 are rejected under 35 U.S.C. 102a1 as being anticipated by Kanuga (Stem Cell Research (2009) 2, 113–12) as evidenced by Sundberg (Investigative Ophthalmology & Visual Science, February 2002, Vol. 43, No. 2, pages 546-555) and Reinisalo (2012, Thesis:Studies on Retina-specific Gene expression, School of Pharmacy, Faculty of Health Sciences, University of Eastern Finland Kuopio ).
Claim 19 and 20 are interpreted as being drawn to an “enriched” population of RPE cells wherein CD56+, CD24+ and/or CD90+ cells have been “depleted”.
Kanuga teaches primary RPE cells obtained from a dissected RPE cell layer which is essentially pure (claim 24,36), at least 95% and 99% pure (claims 22-23,34-35) and “enriched” (all claims). A primary RPE cell line would lack CD56+, CD24+ and/or CD90+ cells (claim 28-31) because these genes are not expressed in RPE, as evidenced by Sundberg, who teaches that these are markers of undifferentiated pluripotent cells or partially differentiated cells of the neural lineage. Claim 21 is met by any pure population of RPE cells as it recites a limitation to an assessment of the population that does not change the population. It is the population being claimed, not a method of obtaining cells. Claims 25-26 recite how cells were removed from the population but because these cells are not part of the population, the cells of Kanuga would meet the claimed enriched population of RPE cells. The cells are not genetically modified when isolated (claim 27,37-38) but some are genetically modified with a nucleic acid encoding SV40 Large T antigen. With regard to claims 39 and 40, PMEL17 and TYRP1 are proteins inherently present in RPE cells and are required for pigmentation as evidenced by Reinisalo.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALARIE BERTOGLIO whose telephone number is (571)272-0725. The examiner can normally be reached on M-F 6AM-2:30PM.
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 on 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 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.
VALARIE E. BERTOGLIO, Ph.D.
Examiner
Art Unit 1632
/VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632
