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 .
Status of the Claims
Claims 203-221 and 223 are currently pending.
Claim 212 and 217 are amended.
Claims 218-221 and 223 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claim 1-202 and 222 are cancelled.
Claims 203-217 have been considered on the merits.
Withdrawn Objections
The objections made onto claims 212 and 217 have been withdrawn in light of the amendments submitted on 03/24/2026.
Claim Interpretation
In the preamble, claim 203 states “A composition for treating a pathological condition in a body part of a patient in need thereof” which is an intended use of the composition. The intended use of the composition carries little patentable weight as the claims are directed to a composition and not a method of use. Therefore, any composition in the prior art possessing the limitations of the composition reads on the instant invention, whether or not the composition is used in the treatment of a pathological condition in a body part of a patient in need thereof. Further, claims 214-217 attempt to furth limit the preamble/ intended use phrasing. Subsequently, claims 214-217 are being interpreted as intended use claims and as previously stated the intended use of the composition carries little patentable weight. Therefore, any composition in the prior art possessing the limitations of the composition reads on claims 214-217.
Claim 203 contains the term “elute” which has been described in the specification as including birth tissue which has been cryopreserved, lyophilized, or frozen (Instant Specification, pg. 2, para 4) as well as “The elute preparation method includes mixing particulates of a birth tissue with a liquid to form a mixture, incubating the mixture, and collecting a supernatant from the mixture. The supernatant is an elute of the birth tissue” (pg. 2, para 3).
Claim 203 contains the phrase “effective amount” and it is being interpreted to mean “an effective amount to treat a pathological condition”.
Claim 203 limits wherein the composition contains an elute of a “first birth tissue” and claim 204 further limits the inclusion of particulates of a “second birth tissue”. In claims 206 and 207, both the first and second birth tissues are limited to selection from an identical group. The claims are being interpreted to require an elute and/or particulates of a single birth tissue, because the instant invention as written allows the possibility that the first and second birth tissue originate from the same tissue.
Claim 208 contains the phrase “wherein the composition is injectable” and it is being interpreted to mean that
Maintained Rejections Necessitated by Amendment
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 203-217 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Werber et al (US20160199417A1).
Regarding claim 203, Werber teaches a composition comprising an elute of a first birth tissue to be “comprises particles of micronized amniotic membrane…In one embodiment, an acellular amnion derived therapeutic composition is a dispersion of micronized amniotic membrane combined with a fluid, such as plasma, saline, amniotic fluid, combinations thereof and the like”([0022]) and elute or particles of a second birth tissue ([0116]) wherein as least one of the tissues is decellularized ([0008]). The composition also includes a pharmaceutically acceptable carrier as required by claims 204 ([0007]). The first and second birth tissue can be interpreted as being one in the same tissue as detailed in the claim interpretation section above however, Werber teaches that a first birth tissue can be amnion/amniotic membrane and Werber teaches a second birth tissue can be chorion, umbilical cord, or amnion/amniotic membrane as required by claims 206 and 207 ([0116]). Werber teaches that the composition contains particulates from the first and/or second birth tissue as required by claim 205 ([0116]).
Werber teaches that the composition is injectable as required by claim 208 ([0014]). Werber teaches that the shear viscosity of the composition may be between or more than 20-250 Pa sec as required by claim 209 ([0030]). Werber teaches that the composition can contain 0.1 mg/ml to 5 mg/ml solubilized collagen as required by claim 210 ([0024]). Werber teaches that the composition can contain hyaluronic acid which are not from the birth tissues as required by claim 211 and 213 ([0040]).
Although the limitations of claims 214-217 are being interpreted as intended use claims and as previously stated in the claim interpretation section above, the intended use of the composition carries little patentable weight, Werber teaches the limitations of claims 214-217. Werber teaches that the composition can be injected into a joint or tissue as required by claim 214 ([0047]). Werber teaches the injection into a knee joint as required by claim 215 (Fig. 9; [0068]). Werber teaches that the tissue can be a tendon, a ligament, and/or a muscle as required by claim 216 ([0047]-[0048]). Werber also teaches that the composition can be used to help treat osteoporotic conditions, which meets the limitations of claim 217 requiring the treatment of a condition from the list including osteoporosis.
Werber does not explicitly disclose that the composition further comprises PRG-4 at a concentration greater than 0.2 ng/MI, a2-macrogobulin at a concentration greater than 4 ug/ml, TGF-beta3 at a concentration at least 0.5 ng/ml, or any combination as required by claim 212. However, claim 212 recites intrinsic properties that are inherent to the composition, which is fully taught by Werber. The specification does not lead one to understand that these components are added separately to the composition, rather that they are the result of having a composition containing an elute of a first birth tissue and particulates of a first and second birth tissue, which is fully taught by Werber. Claim 212 states that the composition further comprises PRG-4 at a concentration greater than 0.2 ng/MI, a2-macrogobulin at a concentration greater than 4 ug/ml, TGF-beta3 at a concentration at least 0.5 ng/ml, which are all directly taught in the specification as being the contents of the elute of the first birth tissue (pg. 5, last para). Further, Table 1 depicts the bioactive factors which are present in the composition, made from the birth tissues without addition of biofactors outside the birth tissues. Therefore, it is apparent that the limitations of claim 212 are intrinsic properties of the composition which is fully taught by Werber. Further, the MPEP states that "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).” (MPEP 2112).
Therefore, Werber anticipates the claims.
Response to Arguments
Applicant's arguments filed 03/24/2026 have been fully considered but they are not persuasive.
Applicant argues (Remarks, pg. 6 last 2 para) that the Applicant does not agree with the claim interpretation of the term “elute” presented in the previous office action. Applicant cites to a description of the elute in the specification which reads “the supernatant is an elute of the birth tissue”(pg. 2, para 3 of spec).
In response, Applicant’s argument is not found persuasive. The specification does not include an explicit definition of the term “elute” at any point. Page 2 of the specification provides description of the elute but does not explicitly define the elute. Applicant asserts that “the elute preparation method includes mixing particulates of a birth tissue with a liquid to form a mixture, incubating the mixture, and collecting a supernatant from the mixture. The supernatant is an elute of the birth tissue” (Spec, pg. 2, para 3) provides a definition of the elute. This is not found to be an explicit definition. Further, the material cited by Applicant includes that the elute is prepared from particulates (pg. 2, para 3 of Spec) and the next paragraph describes “the birth tissue may have been cryopreserved. The birth tissue may have been lyophilized or frozen” which is the description cited in the claim interpretation section in the previous office action. The claim interpretation section has been amended above to include both descriptions of the elute provided on page 2 paragraphs 3 and 4. Since there is not explicit definition provided in the specification, this description is being interpreted to encompass the “elute”. Therefore, the arguments are not found persuasive.
Applicant argues (Remarks, pg. 7-8) that the cited portions of Werber do not teach the elute as described by applicant in the remarks. Further, Applicant asserts that the citation to [0022] of Werber demonstrates that “the Examiner appears to consider the amniotic fluid mentioned at paragraph [0022] of Werber as the elute, since elute could not be plasma or saline”.
In response, Applicant’s arguments are not found persuasive. Applying either Applicant’s or the pervious Office action’s interpretation of the description of the elute of the instant specification, Werber teaches the claimed elute in [0022]. The action does not at any point define or describe the elute as the amniotic fluid as asserted by Applicant. The exact quotation from [0022] reads “comprises particles of micronized amniotic membrane…In one embodiment, an acellular amnion derived therapeutic composition is a dispersion of micronized amniotic membrane combined with a fluid, such as plasma, saline, amniotic fluid, combinations thereof and the like” ([0022]). This quotation from [0022] has been included in the rejection above to demonstrate that [0022] does teach the claimed elute.
Applicant asserts that the definition of the elute is “the elute preparation method includes mixing particulates of a birth tissue with a liquid to form a mixture, incubating the mixture, and collecting a supernatant from the mixture. The supernatant is an elute of the birth tissue” (Spec, pg. 2, para 3). Werber teaches in [0022] that the elute is particulates of a birth tissue, amniotic membrane, mixed with a liquid/fluid which can be plasma, saline, or amniotic fluid. This appears to be identical to the description that Applicant asserts is an explicit definition. Thus, the argument is not found persuasive.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632
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