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 II, claims 8-13, 15, 17-23, 25, drawn to a composition for treating critical limb ischemia, comprising placental ASC, in the reply filed on 05/02/2026 is acknowledged.
Claims 2-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions ], there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/02/2026.
Claim Status
Claims 1, 7, 14, 16, 24, 26-27 are cancelled.
Claims 2-6, 8-13, 15, 17-23, 25 are pending.
Claims 2-6 are non-elected invention.
Claims 8-13, 15, 17-23, 25 are under examination.
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 8-13, 15, 17-23, 25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions (product of nature) without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
Step 1 (Statutory Category): This part of the eligibility analysis evaluates whether the claim falls within any statutory category. Claims 8-13, 15, 17-23, 25 of the instant invention and recite a composition comprising placental adherent stromal cells. Therefore, the claim falls within a statutory category - composition.
Step 2A (Judicial Exceptions), Prong 1: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. All of the claims recite a product of nature, “ placental adherent stromal cells (ASC) ”, in accordance to MPEP 2106.04(c). Placental adherent stromal cells are a product of nature as evidenced by Prather et al.,2009 which teaches that ASC are isolated from placentas (methods, page 428). Thus, the claims recite a judicial exception, a product of nature. Therefore, the analysis proceeds to step 2A prong 2.
Step 2A (Judicial Exceptions), Prong 2: This part of the eligibility analysis evaluates whether the claims as a whole integrate the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claims beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claims as a whole integrate the exception into a practical application.
Claims 8-13, 15, 17-23, 25 recite the ASC composition and the intended use of the said composition. The intended use does not further limit the structure or the function of the ASC composition. Therefore, the additional elements recited in claims 8-13, 15, 17-23, 25 do not integrate the exception into a practical application.
Claims 12-19 recite the process/ method (i.e, culture method) by which the ASC composition was prepared which are product-by-process claims, and the process does not further limit the structure or the function of the product (i.e., ASC composition). Therefore, the additional elements recited in claims 12-19 do not integrate the exception into a practical application.
Claims 21-23 and 25 further limits the structure of the ASC composition. However, the recited limitations/ elements are characteristics of the ASC composition and do not add beyond the judicial exception, and do not integrate the exception into a practical application.
Therefore, the claims as a whole do not integrates the judicial exception into a practical application.
Step 2B (Significantly More): This part of the eligibility analysis evaluates whether the claims as a whole amount to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP 2106.05). This is based on an additional consideration of whether the elements in addition to the judicial exception add beyond what was well-understood, routine, and conventional to the claims.
The elements recited in the claims in addition to the judicial exception do not add significantly more than the recited exception. Claims 8- 11 and 20 further limit the intended use of the ASC composition and fails to further limit the ASC composition. Claims 12-19 further limit the process by which the composition is prepared, and fails to further limit the ASC composition. Claims 21-23 and 25 do not add beyond the judicial exception. Therefore, the claims as a whole fail to amount to significantly more than the recited exception.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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 8-13, 15, 17-23, 25 are rejected under 35 U.S.C. 102 as being anticipated by Prather, William R., et al., Cytotherapy 11.4 (2009): 427-434.
Regarding claims 8 and 10, Prather teaches a composition comprising placental adherent stromal cells (ASC) used for treating critical limb ischemia (CLI) in Balb/c mouse. (background, page 427).
Regarding claim 9 This claim further limits the intended use of the claimed composition but does not change the compositions structure. Prather discloses the claimed ASC cells as described above. As such, the requisite limitations of the claims have been disclosed by Prather.
Regarding claim 11 and 20,
These claims further limit the method of administration of the ASC composition and the intended use of it, and do not further limit the structure of function of the ASC composition. Therefore do not carry patentable weight. Prather discloses the claimed ASC cells as described above. As such, the requisite limitations of the claims have been disclosed by Prather.
Regarding claim 12, This claim recite the method by which the ASC composition is generated, and is considered ‘product-by-process’ and do not carry patentable weight. The invention/claims are evaluated based on the product, i.e., ASC composition, rather than the process by which it was made and the process does not further limit the structure. Prather discloses the claimed ASC cells as described above. As such, the requisite limitations of the claims have been disclosed by Prather.
Regarding claim 13, 15 and 17, 18 , These claims recite the method by which the ASC composition is generated is considered ‘product-by-process’ and do not carry patentable weight. The invention/claims are evaluated based on the product, i.e., ASC composition, rather than the process by which it was made and the process does not further limit the structure. Therefore, claims 13, 15, 17 and 18 do not carry patentable weight. Prather discloses the claimed ASC cells as described above. As such, the requisite limitations of the claims have been disclosed by Prather.
Regarding claim 18, the claims further limit the process by which the ASC are made but to do further limit the structure/function of the ASC. So the teachings of Prather teaches all the limitations of the ASC composition.
Regarding claim 19, Prather teaches the therapeutic value of allogeneically derived placental ASCs for the treatment of CLI in patients (discussion, page 428). Also, all placental ASCs are allogeneic, because they have to be donated and the claim does not specify a donor and a recipient. Therefore, ‘allogenic’ does not impart any additional limitations to the claimed ASCs.Regarding claim 22, Prather teaches the expression of CD73, CD90, CD29 and CD105 on placental ASC composition used to treat CLI (table 1, page 429).
Regarding claims 23 and 25, Prather teaches CD14 (in claim 23) and CD34 (in claims 23 and 25) as negative markers in placental ASCs used to treat CLI ( flow cytometry analysis of cell membrane marker phenotype, page 429).
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 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.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Prather, William R., et al., Cytotherapy 11.4 (2009): 427-434 .
Regarding claim 21, Prather teaches administering 10 million placental ASCs to Balb/c mice to treat CLI. Though Prather does not teach the exact number of cells in the instant claim, Prather delivered effective results with a lower number of cells when mice were treated. Also, it would be obvious to to optimize cell concentration needed for an effective treatment, using routine methods well established in the prior art.
MPEP § 2144.05 (II) states the following:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In reHoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc.v.Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In reKulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying “the need for caution in granting a patent based on the combination of elements found in the prior art.”).
Further the specification does not teach that the claimed number of cells is critical to obtain the claimed ASC composition. Therefore, the claimed subject matter would have been 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.
Therefore, the invention as a whole was a prima facie obvious.Conclusion
No claims allowed
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/HASHANTHI KOMITIGE ABEYRATNE-PERERA/Examiner, Art Unit 1632
/MARCIA S NOBLE/Primary Examiner, Art Unit 1632
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