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 .
Applicants’ response of 9/17/2026 has been received and entered into the application file. Claims 1-5, 7-14, and 16-20 remain pending, all of which have been considered on the merits.
Claim Interpretation
For clarity of record the following comments are made regarding claim interpretation:
The broadest reasonable interpretation of claim 1 is that it is a composition comprising the two parts (a) and (b). In one embodiment, (a) and (b) may be mixed together (i.e. the claimed composition is a singular composition). In an alternative embodiment, (a) and (b) may be provided separately and intended for mixing.
In light of the specification “aqueous human umbilical cord filtrate” is interpreted as meaning an aqueous solution which is derived from and/or has been in contact with human umbilical cord, which contains at least some molecules from human umbilical cord, and which has been passed through a filter. Notably, the composition is not considered to read on pure isotonic buffer, such as PBS.
In claim 1 the recitation in the preamble that the two-part clotting composition is ‘configured for wound packing and/or dental purposes and/or dental treatments’ is considered to limit the two-part clotting composition only in so far as it must be physically capable of being applied to a wound and/or applied to dental tissue or dental materials. Any liquid, semi-solid, or solid material will meet these requirements.
Furthermore, in claim 1, the recitation that the aqueous human umbilical cord filtrate is ‘configured to reconstitute the micronized human umbilical cord composition’ is considered to limit the aqueous human umbilical cord filtrate only in so far as it must be physically capable of reconstituting the micronized human umbilical cord composition. By virtue of the aqueous human umbilical cord filtrate being aqueous, it will necessarily be considered physically capable of reconstituting the micronized human umbilical cord composition.
In claim 7, lines 6-7, the reference to the particle size ranging from 50 nm to 200 nm is understood to be referring to the size of the exosomes.
Status of Prior Rejections/Response to Arguments
RE: Objection to claims 4, 7 and 8:
The amendment to claims 4, 7 and 8 obviate the previous basis for the objections. However, cancellation of claim 5 necessitates a new ground of objection over claim 7 (see below).
RE: Rejection of claims 12, 15 and 17-20 under 35 USC 112(b): Cancellation of claim 15 renders the rejection thereof moot.
The amendment to claims 12, 17 and 18 are effective to obviate the previous basis of the rejections. The rejections are withdrawn.
RE: Rejection of claims 15 and 16 under 35 USC 112(d):
Cancellation of claim 15 renders the rejection thereof moot.
Applicants assert the amendment to claim 16 overcomes the rejection because it adds a clear step. However, this does not address the issue because claim 16 is a product claim. It is not clear how the recited active step further limits the composition of claim 1. The rejection is maintained.
RE: Rejection of claims 1, 2, 11 and 13-16 under 35 USC 102(a)(1) over Spencer et al (US 2015/0335686):
Cancellation of claim 15 renders the rejection thereof moot.
Applicants argue that Spencer et al does not teach all limitations of amended claim 1. It appears Applicants are arguing that because claim 6 was not previously rejected, claim 1 is now allowable. However, claim 1 did not incorporate all limitations of previous claim 6. Previous claim 6 depended on claim 5, which depended on claim 4, which depended on claim 3, which depended on claim 2. The limitations of claims 3-5 have not been incorporated into claim 1.
Spencer et al teaches a composition comprising micronized human Wharton’s jelly. Spencer et al teaches Wharton’s jelly contains, inter alia, collagen and chondroitin sulfate (an sGAG) (See ¶0004). Thus the micronized Wharton’s jelly of Spencer et al does meet the limitation of amended claim 1. The rejection is maintained/modified to address the amended claims.
RE: Rejection of claims 1-20 on grounds of NSDP over claims of US Patent 1184486:
Applicants did not traverse the rejection. The rejection is maintained/modified to address the amended claims.
RE: Provisional rejection of claims 1, 3, 4, 11, 15 and 16 on grounds of NSDP over claims of copending US applications 17/873383, 18/130555, 18/735328 and 19/056248:
Applicants did not traverse the rejections. The rejections are maintained/modified to address the amended claims.
Claim Objections
Claim 7 is objected to for minor informalities:
Claim 7 is now the first time the abbreviations “IGFBP-1” is used. The full word should precede the first use of the abbreviation. The full term should be added claim 7. Correction is required.
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.
Claim 16 is 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.
Regarding claim 16: Claim 16 recites an active method step, however the claim is drawn to a composition of matter. The recitation of an active method step renders the claim indefinite, as it is not clear if the claim intends to cover the composition per se, or a method of using the composition.
Claim Rejections - 35 USC § 112
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 16 is 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.
Regarding claim 16: Parent claim 1 states the composition is configured for wound packing and/or dental purposes and/or dental treatments. This has been interpreted as meaning the composition can be physically applied to a wound and/or applied to dental tissue or dental materials. Any liquid, semi-solid, or solid material will meet these requirements. Claim 16 appears to states how the wound would be packed, but this does not further limit the form or provide any further limitations on the material and is thus rejected on the same basis.
Applicants 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.
Claims 1, 2, 11, 13, 14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spencer et al (US 2015/0335686).
This rejection is made over the claim embodiment wherein (a) and (b) are provided together, as a singular composition.
Spencer et al teaches compositions of micronized human Wharton’s jelly having controlled viscosity making it suitable for delivery to an injured tissue site in a subject for repair of said injured tissue site (See abstract). Specifically, Spencer et al teach isolating human umbilical cord, and optionally further isolating out the Wharton’s jelly (See ¶0040-0041). Spencer et al teach processing either entire isolated umbilical cord or the isolated Wharton’s jelly, they collectively referred to these as “Umbilical Cord Tissue” (See ¶0040). The isolated Umbilical Cord Tissue is then dehydrated, micronized, and then suspending the micronized umbilical cord tissue in a pharmaceutically acceptable aqueous carrier to form a suspension or gelatinous gel composition having a desired viscosity (See ¶0042-0064).
It is acknowledged that the final suspension or gelatinous gel composition is different from the currently claimed two-part clotting composition because the pharmaceutically acceptable carriers are not equivalent to a human umbilical cord filtrate.
However, an intermediate product formed during the preparation process of Spencer et al is being relied upon for this rejection:
At ¶0054 Spencer et al teach suspending the micronized Wharton’s jelly in water and then fractionating based on particle size. In this mixture prior to fractionation, the micronized Wharton’s jelly reads on micronized human umbilical cord composition, and the water reads on an aqueous human umbilical cord filtrate, as the water has been in contact with the human umbilical cord, and will thus necessarily contain elements of the human umbilical cord. Wharton’s jelly contains, inter alia, collagen and chondroitin sulfate (a sGAG) (See ¶0004). This mixture reads on the two-part clotting composition of claim 1.
The composition also satisfies the limitation of claim 2, as the umbilical cord is never subject to enzymatic digestion.
The composition is considered to inherently satisfy the limitation of claim 11 because the suspension will necessarily contain particles sized less than 100 µm in diameter from the umbilical cord tissue, e.g. proteins, etc.
The composition also satisfies the limitation of claims 13 and 14, as the water is sterile water, and will be non-immunogenic to at least the donor of the umbilical cord tissue.
The composition will also satisfy the limitations of claim 16 as a liquid suspension is capable of being used in wound packing (can be admixed with additional thickening agents and/or applied to a matrix material) or can be applied to dental tissues.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 7-14 and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11844876.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the instant claims as follows:
Regarding claim 1: Patented claim 1 is drawn to a kit comprising the same two elements required in the currently claimed two-part clotting composition. This rejection is made over the claim interpretation that (a) and (b) can be provided separately. Patented claim 8 teaches the composition comprises collagen, sGAGs, and exosomes. Patented claim 8 anticipates instant claim 1.
Regarding claim 2: Patented claim 4 teaches the limitations of instant claim 2.
Regarding claims 3-5 and 7: Patented claims 7-9 teach and/or render obvious the limitations of instant claims 3-5 and 7.
Regarding claim 8: Patented claim 9 teaches the limitations of instant claim 8.
Regarding claims 9 and 10: Patented claims 10-11 teach the limitations of instant claims 9-10.
Regarding claim 11: Patented claim 12 teaches the limitations of instant claim 11.
Regarding claim 12: Selection of the appropriate ratio would have been obvious, at least in view of patent claim 18.
Regarding claims 13-14: Use of sterile and non-immunogenic components would have been prima facie obvious in the patented claims, as the composition is intended for application to the human body (see patented claims 17-20).
Regarding claim 16: As claim 16 does not further limit parent claim 1, claim 16 is rejected for the same reason as claim 1.
Regarding claims 17-20: Patented claims 17-20 teach the limitations of instant claims 17-20, respectively.
Claims 1, 3, 4, 11, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-14 of copending U.S. Application No. 17/873383.
The copending US Application has been allowed, but not yet issued. Upon issuance, the rejection will become non-provisional.
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the instant claims as follows:
Regarding claims 1 and 11: Copending claim 1 discloses an aqueous, non-immunogenic, injectable composition comprising, an aqueous human umbilical cord filtrate …having particulates of less than 100 µm, and, inter alia, acellular Wharton’s jelly and exosomes. This rejection is made over the claim interpretation that (a) and (b) can be together in a singular composition. The aqueous human umbilical cord filtrate reads on (b) an aqueous human umbilical cord filtrate, and the acellular Wharton’s jelly at least renders obvious (a) micronized human umbilical cord composition. The composition further comprises exosomes. Though the copending claim doesn’t state the acellular Wharton’s jelly is micronized, the fact that the overall composition is aqueous and injectable means the acellular Whartons jelly must be in a form small enough to be provided in suspension and injected through a delivery device. This at least renders obvious micronization.
Regarding claims 3-4: Copending claims 3 and 4 teach further inclusion of an isotonic solution, such as PBS.
Regarding claim16: An aqueous composition suitable for injection can also be considered to meet the limitation configured for wound packing, as it can be applied to a matrix or material for wound packing.
Claims 1, 3, 4, 11 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of copending U.S. Application No. 18/130555.
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the instant claims as follows:
Regarding claim 1: Copending claim 4 discloses an aqueous injectable composition comprising an aqueous human umbilical cord filtrate, sGAGs, exosomes, HGF, and, inter alia, acellular Wharton’s jelly. This rejection is made over the claim interpretation that (a) and (b) can be together in a singular composition. The aqueous human umbilical cord filtrate reads on (b) an aqueous human umbilical cord filtrate, and the acellular Wharton’s jelly at least renders obvious (a) micronized human umbilical cord composition. Though the copending claim doesn’t state the acellular Wharton’s jelly is micronized, the fact that the overall composition is aqueous and injectable means the acellular Whartons jelly must be in a form small enough to be provided in suspension and injected through a delivery device. This at least renders obvious micronization.
Regarding claims 3-4: Copending claims 5 and 6 teach further inclusion of an isotonic solution, such as PBS.
Regarding claim 11: Copending claim 7 teaches the filtrate contains particles from human umbilical cord less than 100 µm in diameter.
Regarding claim 16: An aqueous composition suitable for injection can also be considered to meet the limitation configured for wound packing, as it can be applied to a matrix or material for wound packing.
Claims 1, 3, 4, 11, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of copending U.S. Application No. 18/735328.
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the instant claims as follows:
Regarding claims 1 and 11: Copending claim 2 discloses an aqueous injectable composition comprising an aqueous human umbilical cord filtrate comprising particulates of less than 100 µm in diameter and, inter alia, exosomes and acellular Wharton’s jelly. This rejection is made over the claim interpretation that (a) and (b) can be together in a singular composition. The aqueous human umbilical cord filtrate reads on (b) an aqueous human umbilical cord filtrate, and the acellular Wharton’s jelly at least renders obvious (a) micronized human umbilical cord composition. Though the copending claim doesn’t state the acellular Wharton’s jelly is micronized, the fact that the overall composition is aqueous and injectable means the acellular Whartons jelly must be in a form small enough to be provided in suspension and injected through a delivery device. This at least renders obvious micronization.
Regarding claims 3-4: Copending claims 6 and 7 teach further inclusion of an isotonic solution, such as PBS.
Regarding claim 16: An aqueous composition suitable for injection can also be considered to meet the limitation configured for wound packing, as it can be applied to a matrix or material for wound packing.
Claims 1, 3, 4, 11 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of copending U.S. Application No. 19/056248.
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the instant claims as follows:
Regarding claim 1: Copending claim 4 discloses an aqueous injectable composition comprising an aqueous human umbilical cord filtrate comprising particulates of less than 100 µm in diameter and, inter alia, exosomes, HGF, sGAGs, fibronectin, and acellular Wharton’s jelly. This rejection is made over the claim interpretation that (a) and (b) can be together in a singular composition. The aqueous human umbilical cord filtrate reads on (b) an aqueous human umbilical cord filtrate, and the acellular Wharton’s jelly at least renders obvious (a) micronized human umbilical cord composition. Though the copending claim doesn’t state the acellular Wharton’s jelly is micronized, the fact that the overall composition is aqueous and injectable means the acellular Whartons jelly must be in a form small enough to be provided in suspension and injected through a delivery device. This at least renders obvious micronization.
Regarding claims 3-4: Copending claims 6 and 7 teach further inclusion of an isotonic solution, such as PBS.
Regarding claim 11: Copending claim 3 teaches the filtrate contains particles from human umbilical cord less than 100 µm in diameter.
Regarding claim 16: An aqueous composition suitable for injection can also be considered to meet the limitation configured for wound packing, as it can be applied to a matrix or material for wound packing.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached on 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALLISON M FOX/Primary Examiner, Art Unit 1633
