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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/6/2026, including the amendments to drawings and specification, have been entered.
Claims 1 and 3-16 are current pending.
Election/Restrictions
Applicants previously elected Group I, drawn to a composition of placental particles. Claims 1, 3-8 and 16 read on the elected invention. Claims 9-15 are withdrawn from consideration, pursuant to 37 CFR 1.142(b).
Claim Interpretation
Claim 1 is directed to a composition comprising placenta-derived particles (PP composition). The PP composition can include any one or more of: amnion-derived membrane particles (APs), chorionic membrane derived particles (CPs), umbilical cord derived particles (UCPs), and chorionic plate derived particles (CPP). In the broadest interpretation, a minimum of only one type of PP is required, but the claim scope also covers compositions comprising mixtures of two, three, or all four types of PPs, as well as additional, unrecited components. The claim now limits the PPs present in the composition to have a size distribution at the defined percentages.
Claim 5 requires both APs and CPs to be present. UCPs and CPPs are further optionally present. Claim 5 sets forth the dry weight percentage of each of the APs and CPs in the composition and, if present, the dry weight percentages of UCPs and CPPs present in the PP composition.
Claim 6 requires all of APs, CPs, UCPs and CPPs to be present. Claim 6 sets forth the dry weight percentage of each of the APs, CPs, UCPs and CPPs in the composition
Claim 7 is interpreted as requiring the PP composition to comprise APs, CPs and either UCPs or CPPs (but not both), and for each of these components to be present at the defined percentages.
Claim 8 requires all of APs, CPs, UCPs and CPPs to be present. Claim 8 sets forth the dry weight percentage of each of the APs, CPs, UCPs and CPPs in the composition.
Claim 16 is interpreted in the same manner as claim 1. Claim 16 further limits the size distribution of particles present in greater detail than claim 1.
Declaration under 37 CFR 1.132
A declaration by inventor Dr Kevin Wu was submitted on 2/6/2026. The declaration has been entered into the record.
Status of Rejections/Response to Arguments
RE: Objection to Specification:
The amendment to the specification corrects the issue. The objection is withdrawn.
RE: Objection to Drawings:
The replacement drawings of 2/6/2026 have been entered. With the replacement drawings, there are no more color images in the drawings. The objection is withdrawn.
RE: Rejection of claims 1, 5-8 and 16 under 35 USC 112(a):
Applicants assert the bar graphs of Fig. 2A, 2B and 2C provide support for the proportion and particle size ranges recited in the current claims. Applicants assert the data provided in the 37 CFR 1.132 declaration is the raw data used to generate these graphs and supports the ranges in the current claims. Applicants also assert the actual experimental particle size distribution data was not required for persons of ordinary skill to discern and understand the basis for each of the claimed ranges for particle size distribution of the PP in the PP composition.
It is respectfully submitted that the bar graphs provide insufficient detail to provide for the claimed ranges.
The following is considered a reasonable interpretation of information that can be discerned from Fig. 2A, 2B and 2C:
For Fig. 2A:
Particle size (µm)
Donor A
Donor B
Donor C
0
0%
0%
0%
25
~11%
~13%
~6%
50
~17%
~34%
~20%
75
~16%
~17%
~18%
100
~15%
~11%
~7%
125
~10%
~5%
~12%
150
~9%
~3%
~9%
Total
~78%
~83%
~72%
500
~3%
~5%
~4%
1000
~2%
~3%
~7%
4000
~3%
~2%
~4%
Total
~8%
~10%
~15%
For Fig. 2B:
Particle size (µm)
Donor D
Donor E
Donor F
0
0%
0%
0%
25
~33%
~30%
~25%
50
~20%
~19%
~18%
75
~12%
~14%
~13%
100
~8%
~8%
~8%
125
~6%
~6%
~6%
150
~4%
~4%
~5%
Total
~83%
~81%
~75%
500
~5%
~4%
~8%
1000
~3%
~3%
~4%
4000
~2%
~2%
~2%
Total
~10%
~9%
~14%
For Fig. 2C:
Particle size (µm)
Donor G
Donor H
Donor I
0
0%
0%
0%
25
~45%
~46%
~45%
50
~24%
~25%
~24%
75
~9%
~8%
~9%
100
~5%
~4%
~5%
125
~4%
~3%
~4%
150
~3%
~2%
~3%
Total
~90%
~88%
~90%
500
~3%
~3%
~3%
1000
~2%
~2%
~2%
4000
~1%
~1%
~1%
Total
~6%
~6%
~5%
It is appreciated that the declaration provides more specific values that were used to generate Figs 2A, 2B and 2C, however that information is not part of the original disclosure and cannot be imported or relied upon to provide support in the manner required by 35 USC 112(a). It is noted that even if the values in the declaration could be relied upon (which they cannot) they still do not provide support for the specific ranges claimed. At most, the declaration appears to identify different values than those claimed, specifically 73.5–88.8% as the proportion of PP sized less than 150 microns and 3.1–10.2% as the proportion of PP sized greater than 500 to 4000 microns. While these values are close to the currently claimed range limits, they are not the same.
At this time it remains that the following limitations do not find support in the original disclosure: (in claims 1 and 16) that from 70% to 90% of the total population of PP be 150 microns or less;
(in claims 1 and 16) that from 3% to 11% of the total population of PP be greater than 500 to 4000 microns;
(in claim 16) that from 7% to 19% of the total population of PP be 150 to 500 microns.
The rejection has been modified to address the current claim limitations.
RE: Rejection of claims 1 and 3-7 under 35 USC 103 over Pavesio et al:
The amendment to claim 1 to require 3-11% of the total particles to have a size from greater than 500 µm to 4000 µm is effective to differentiate from the composition of Pavesio et al. The relied upon embodiment of Pavesio et al contained particles having a size of about 5-300 µm, preferably around 20-150 µm. While the sieving process of Pavesio et al would allow for some particles with slightly larger dimensions than the largest recited size (e.g. slightly larger than 300 µm or slightly larger than 150 µm), there would be no expectation that 3-11% of the particles would have dimensions in the greater than 500 µm to 4000 µm range. The rejection is withdrawn.
RE: Rejection of claims 1-6, 8 and 16 under 35 USC 103 over LeVaughn et al:
The amendment to claim 1 to require 3-11% of the total particles to have a size from greater than 500 µm to 4000 µm is effective to differentiate from the composition of LeVaughn et al. The relied upon embodiment of LeVaughn et al contained particles having about 50-500 µm, preferably around 50-150 µm. While the production process of LeVaughn et al would allow for some particles with slightly larger dimensions than the largest recited size (e.g. slightly larger than 500 µm or slightly larger than 150 µm), there would be no expectation that 3-11% of the particles would have dimensions in the greater than 500 µm to 4000 µm range. The rejection is withdrawn.
RE: Provisional NSDP over copending application 17/778333:
Applicant has not traversed the rejection of record.
However, in light of the amendment to claim 1, requiring 3-11% of the particles to have a size from greater than 500 µm to 4000 µm, the provisional rejection is withdrawn. The copending claims recite the AM, CM and UC particulates have a particle size in the range from about 20 to about 150 microns. No larger sized particles are contemplated or claimed.
RE: Provisional NSDP over copending application 18/608371:
Applicant has not traversed the rejection of record.
However, in light of the amendment to claim 1, requiring 3-11% of the particles to have a size from greater than 500 µm to 4000 µm, the provisional rejection is withdrawn. None of the remaining copending claims recite particle sizes.
New/Maintained Rejections
Claim Rejections - 35 USC § 112
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.
Claims 1, 3-8 and 16 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.
Claim 1 has been amended to require that the composition comprises:
from 70% to 90% of the total PP population being 150 µm or less, and
from 3% to 11% of the total PP population being greater than 500 µm to 4000 µm.
Claim 16 requires the composition comprises:
from 70% to 90% of the total PP population being 150µm or less,
from 7% to 19% of the total PP population being from greater than 150µm to less than 500 µm, and
from 3% to 11% of the total PP population being greater than 500 µm to 4000 µm.
There is no explicit support for the italicized ranges in the original disclosure. Thus these limitations are considered new matter. The originally filed specification does not recite the end points of any of the italicized ranges. Applicants point to Fig. 2A, 2B and 2C and to the information provided in the 2/6/2026 declaration for support.
First, regarding the information provided in the 2/6/2026 declaration: while this information has been reviewed, the raw data relied upon in the declaration was not included in the application as originally filed and cannot provide written description support for newly claimed numerical ranges.
Second, regarding Fig. 2A, 2B and 2C: Examiner has set forth a chart of data points that can reasonably be derived from the bar graphs of Fig. 2A, 2B and 2C. While the charts provide % falling within the claimed ranges (e.g. ~78% or ~83% of PPs being 150 microns or less), they do not clearly support the end points of each of these claimed ranges. Disclosure of values that fall within a range does not necessarily support a broader range encompassing that value, particularly when Applicants have asserted the claimed ranges are critical.
All of dependent claims 3-8 require 3% to 11% of the total PP population being from greater than 500 µ to 4000 µm, and thus are included in this rejection.
Applicant is invited to identify specific support in the application as originally filed showing that the claimed endpoints were disclosed or would have been reasonably understood by a POSITA from the originally filed disclosure.
Applicants are notified that the addition of the new matter has necessitated withdrawal of one or more prior art rejections. Removal of the new matter may result in reinstatement of the prior art rejections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLISON M FOX whose telephone number is (571)272-2936. The examiner can normally be reached M-F 10-6 EST.
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/ALLISON M FOX/Primary Examiner, Art Unit 1633
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