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 .
DETAILED ACTION
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 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.
Response to Amendments
Applicant’s amendments, corrected specification, and response filed Nov. 6, 2025 have been received and entered into the case.
Election/Restrictions
It is noted in the Remarks filed on Nov. 6, 2025, no affirmation of the election was made by the applicant in replying to the Office action mailed on Aug. 1, 2025. During a telephone conversation with Attorney Hussein Akhavannik on Jul. 21, 2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-9.
Newly amended claim 8 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the original elected claims are drawn to a processed adipose tissue and newly amended claim 8 now recites a method of implanting or injecting an allograft into a patient and would have been restricted from Inventions I-III.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 8 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Status of the Claims
Claims 1-9 and 29-49 are currently pending.
Claim 8 has 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.
Claims 1-9 are amended.
Claims 10-28 are cancelled.
Claims 29-49 are new.
Claims 1-7, 9 and 29-49 have been considered on the merits.
Claim Interpretation
In claim 1, the term, “minimally manipulating” is being interpreted as defined in the specification in 0144 of the published application as “processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement”.
Specification Objections
Specification objections are withdrawn due to amendment.
Claim Rejections - 35 USC § 112
New claim rejections under 35 USC § 112, (a) or first paragraph (pre-AIA ) have been added to address the claim amendments.
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 1-8 and 29-49 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 claims contain 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 pre-AIA the inventors, at the time the application was filed, had possession of the claimed invention. Claim 1 recites a limitation of “intact adipocyte cells having a surface area that is at least 10% of a surface area of the adipocyte cells of a native adipose tissue”. The specification describes the composition having an intact adipocyte composition of 10% (para. 0007 of published application). However, there is no description of the composition where the intact adipocyte composition has a surface area of 10% of the adipocyte cells of a native adipose tissue. Similarly, claims 2-5 recite the intact adipocyte cells having a surface area that is at least 30%, 30-70%, 30-55%, or 45-70% of a surface area of the adipocyte cells of a native adipose tissue, respectively. The specification describes the composition having an intact adipocyte composition of 30%, 30-70%, 30-55%, or 45-70% (para. 0007 of published application). However, there is no description of the composition where the intact adipocyte composition has a surface area of 30%, 30-70%, 30-55%, or 45-70% of the adipocyte cells of a native adipose tissue. Likewise, claim 44 recites “intact adipocyte cells having a surface area from 30% to 70% of a surface area of the adipocyte cells of a native adipose tissue”. The specification describes the composition having an intact adipocyte composition of 30-70% (para. 0007 of published application). However, there is no description of the composition where the intact adipocyte composition has a surface area of 30%, 30-70%, 30-55%, or 45-70% of the adipocyte cells of a native adipose tissue.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under USC 112 for the reasons set forth above.
This is a new matter rejection.
The claim rejections under 35 USC § 112, (b) or second paragraph (pre-AIA ), are withdrawn due to amendment. New claim rejections under 35 USC § 112, (b) or second paragraph (pre-AIA ) have been added to address the claim amendments.
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 9, 29-31, 37, and 44-49 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.
Claims 9, 29-31, and 44 are rendered indefinite for containing the phrase, “configured to” which implies steps must occur to meet the limitation. However, no steps are recited making the claims indefinite in scope. It is unclear what steps need to be performed so that the processed adipose tissue is to be passed through an opening of 4.5 mm, 2 mm, 1.5 mm, or 1 mm, respectively. Additionally, the claims are directed to a composition and not a method.
In claim 37, the phrase “wherein the amount of lipids is less than or equal to 80 wt%, based on the total weight of the allograft”, renders the claim and its dependents indefinite, since it is unclear whether this limitation is meant to include lipid amounts less than 47% as recited in claim 1 from which claim 37 depends from. For the purposes of compact prosecution, the claims will be interpreted to mean “wherein the amount of lipids is greater than or equal to 47 wt% and less than and equal to 80 wt%.
Since claims 45-49 either depend from indefinite claim 44 or contain the composition of claim 44 and do not clarify the above points of confusion, claims 45-49 must also be rejected under 35 U.S.C. § 112, second paragraph.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
The claim rejections under 35 USC § 101 are withdrawn due to amendment.
Claim Rejections - 35 USC § 102
The claim rejections under 35 USC § 102 are withdrawn due to amendment.
Claim Rejections - 35 USC § 103
The claim rejections under 35 USC § 103 are withdrawn due to amendment. New claim rejections under 35 USC § 103 have been added to address the claim amendments.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-8, 29-42 and 44-49 are rejected under 35 U.S.C. 103 as being unpatentable over Danilkovitch (US 2023/0063467 A1, priority to Aug. 12, 2021) as evidenced by Bi et al. (Frontiers in Cell and Developmental Biology, 2021) and McKee et al. (Scientific Reports, 2019).
With respect to claims 1 and 44, Danilkovitch teaches a composition derived from a native adipose tissue containing adipocytes for the purpose of administering to a subject (an allograft) (abstract, 0006-0009 and 0109). The composition of Danilkovitch meets the limitation of minimally manipulated, since Danilkovitch teaches the retention of cells and the instant specification explains that minimally manipulation of the composition can be measured by the retention of structurally intact adipocytes (0146 of published application). In addition, minimally manipulating is defined in the specification in 0144 of the published application as “processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement”. Danilkovitch composition meets this definition, since Danilkovitch teaches the composition where the devitalized adipose tissue contains all of the components of native adipose tissue except for a portion of the lipids and some cells (0069) and according to the definition in the specification is minimally manipulated.
Further with respect to claims 1 and 44, Danilkovitch teaches the composition (allograft) containing an adipose matrix (extracellular matrix) (0087). Additionally, Danilkovitch teach the composition is adipose tissue which would be readily understood to contain the extracellular matrix of adipose tissue and since Danilkovitch does not expressly teach removing of any matrix components.
With respect to claims 1-5 and 44, Danilkovitch teaches the composition (allograft) of devitalized adipose tissue contains retained cells (adipocytes) that are 100, 90, 85, 80, 75, 70, 65, 60, 55, or 50% of the cells present in the adipose tissue prior to devitalization (0071). Danilkovitch reports viability of the cells in Table 3 which shows in at least living donors an average of 14,011 ± 8820 viable cells in processed adipose tissue and an average of 36,369 ± 20090 viable cells in unprocessed adipose tissue which give about 39% retained viable cells in the processed tissue (Table 3). Additionally, the viable adipocytes would be intact. Although Danilkovitch does not teach the relationship of the surface area of the intact adipocytes of the processed tissue with the adipocytes of the native adipose tissue as recited in claims 1-5 and 44, one of ordinary skill in the art would reasonably presume or predict that the numbers of cells and surface area of the cells would correlate.
With respect to claims 1 and 44, Danilkovitch teaches the composition (allograft) containing lipids in an amount of at least 50% based on the total weight of the composition (allograft) (0088).
With respect to claims 1 and 47, Danilkovitch teaches the composition (allograft) where the cryopreserved adipose tissue has significantly reduced levels of TNF-α compared to fresh processed tissue (containing fewer allogenic components than the native adipose tissue) (0160).
Although, Danilkovitch is silent with respect to whether the adipose matrix or extracellular matrix contains collagen, glycoproteins or proteoglycan from the native adipose tissue as recited in claim 6, the extracellular matrix of adipose tissue inherently contains these components as evidenced by Bi. Bi reports that adipose extracellular matrix is composed of collagen, proteoglycans, thrombospondin and fibronectin (glycoproteins) (pg. 2 Col. 1 para. 2). Danilkovitch does not teach the removal of proteins or matrix from the adipose tissue, therefore, these components would be present in the composition of Danilkovitch.
With respect to claim 7, Danilkovitch teaches the composition (allograft) where the adipose tissue is decellularized with a reduced amount of cellular components relative to the native adipose tissue (0071).
With respect to claims 9 and 44, Danilkovitch teaches the composition (allograft) is processed to be less than 1 mm or less than 2 mm in size (would be able to be passed through an opening of 4.5 mm) (0068). With respect to claims 29-31, Danilkovitch teaches the composition (allograft) is processed to be less than 1 mm or less than 2 mm in size (would be able to be passed through an openings of 2 mm, 1.5 mm, and 1mm as recited in claims 29-31, respectively) (0068).
With respect to claim 32, Danilkovitch teaches the native tissue is human (0135, Example 1). With respect to claims 33 and 34, Danilkovitch teaches the composition having less cells than native adipose tissue, therefore there are less nucleic acids and intracellular components of the intact adipocyte cells in the processed composition of Danilkovitch (0071 and Table 3).
With respect to claim 35, Danilkovitch reports viability of the cells in Table 3 which shows in at least living donors an average of 14,011 ± 8820 viable cells in processed adipose and an average of 36,369 ± 20090 viable cells in unprocessed adipose which would be about 39% retained cells in the processed adipose tissue compared to the unprocessed adipose tissue (Table 3). The cells would have to be structurally intact if they are viable.
With respect to claims 36 and 46, Danilkovitch teaches mechanically sizing the composition (allograft) down from the native adipose tissue (0068)
With respect to claim 37, Danilkovitch teaches the composition (allograft) containing lipids in an amount of at least 50% based on the total weight of the composition (allograft) and in an amount less than 80% based on the total weight of the composition (allograft) (0088).
With respect to claims 38 and 44, Danilkovitch teaches rehydrating the adipose tissue products (0145). With respect to claim 39, Danilkovitch teaches lyophilized adipose tissue having less than 15% residual water (0093).
With respect to claims 40 and 44, Danilkovitch teaches “the devitalized adipose tissue comprises all of the components of native adipose tissue except for a portion of the lipids and some cells” and contains native adipose tissue factors (0069). Although Danilkovitch is silent with respect to the protein content of the adipose composition and does not teach that the allograft has proteins in an amount of from 2-7 wt% based on the total weight of the allograft as recited in claims 40 and 44, Danilkovitch teaches the composition containing all components of native adipose tissue which would include the proteins. Native adipose tissues contains 3-5 wt% protein as evidenced by McKee. McKee reports that natural adipose tissue contains over 75-80% lipids and about 15-20% water, and 3-5% protein (Fig. 7).
With respect to claims 41-42 and 48-49, Danilkovitch teaches a glass vial or syringe containing or prefilled with the composition or allograft (0141 and 0161).
With respect to claim 45, Danilkovitch teaches “the devitalized adipose tissue comprises all of the components of native adipose tissue except for a portion of the lipids and some cells” and contains native adipose tissue factors (0069). Although Danilkovitch is silent with respect to the water content of the hydrated adipose composition and does not teach that the composition or allograft has water in an amount of from 19-47 wt% based on the total weight of the hydrated allograft as recited in claim 45, Danilkovitch teaches the composition containing all components of native adipose tissue which would include the proteins. Native adipose tissues contains about 15-20% protein as evidenced by McKee. McKee reports that natural adipose tissue contains over 75-80% lipids and about 15-20% water, and 3-5% protein (Fig. 7).
Therefore, the invention as a whole was prima facie 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.
Claim 43 is rejected under 35 U.S.C. 103(a) as being unpatentable over Danilkovitch in view of as evidenced by Bi and McKee (as applied to claims 1-8, 29-42 and 44-49 above), and further in view of Bi et al. (Frontiers in Cell and Developmental Biology, 2021).
The teachings of Danilkovitch can be found in the previous rejection above.
Although, Danilkovitch teaches the container is syringe which would readily understood by those skilled in the art to be used with a needle or cannula (0141), Danilkovitch does not explicitly teach the pre-filled container containing a cannula configured to be attached to the syringe as recited in claim 43.
However, Bi teaches an allograft derived from adipose tissue in a syringe with cannula (Fig. 1). Bi also reports that during fat injection the cannula is first driven in to create a tunnel the recipient tissue prior to the fat injection (pg. 9 Col. 2 para. 5).
Accordingly, at the effective time of filing of the claimed invention one of ordinary skill in the art would have been motivated to modify the pre-filled syringe of Danilkovitch to include or be attached to a cannula for the benefit of being able to delivery the processed adipose tissue composition or allograft to a patient. It would have been obvious to one of ordinary skill in the art to make such a modification, since it was well-known in the art that syringes attached to cannulas were used for grafting adipose tissue into patients as taught by Bi. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to the syringe of Danilkovitch, since Bi teaches syringes containing fat tissue attached to cannulas.
Therefore, the invention as a whole was prima facie 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.
Response to Arguments
Applicant's arguments filed Nov. 6, 2025 have been fully considered but they are not persuasive.
With respect to the rejections under 35 U.S.C. § 102 and 103 based on Fradette, Applicant argues that Fradette is directed to deriving tissues and sheets from adipose derived-stromal cells and does not teach a scaffold derived from natural native adipose tissue (Remarks pg. 8 para. 3 to pg. 9 para. 3). The Applicant’s amendments limiting claim 1 to include numerous new limitations necessitated the withdrawal of the previous rejection. Applicant’s arguments are drawn to Fradette failing to teach the new limitation of a scaffold derived from natural native adipose tissue. However, this new limitation is addressed in the new rejections.
In addition, Applicant argues that Nahas does not remedy the deficiencies of Fradette (Remarks pg. 9 para. 4). However, this argument was not found to be persuasive, since the arguments with respect to the rejections over Fradette were not found to be persuasive as explained above.
With respect to the rejections under 35 U.S.C. § 103 based on Chi, Applicant argues that Chi is directed to culturing and differentiating adipose-derived stem cells for cell therapy and the lysing of adipocytes (Remarks pg. 9 para. 6). Applicant further argues that Chi teaches away from retaining adipocytes from native tissue, since Chi teaches that adipocytes are fragile and destroyed during processing (Remarks pg. 9-10 bridging para.). In addition, applicant argues that Chi teaches away from allograft containing an extracellular matrix from native tissue with intact adipocytes having a surface area that is at least 10% of a surface area of the adipocyte cells of the native tissue and lipids in the amount of at least 47% based on the total weight of the allograft (Remarks pg. 10 para. 2). Applicant’s arguments are drawn to Chi failing to teach the new limitations of the claims. However, the new limitations are addressed in the new rejections.
Applicant argues Nahas teaches away from the allograft having at least 47% lipids, since Nahas discloses removing the lipids from the adipose tissue, since lipids induce inflammation and toxicity (Remarks pg. 10 para. 4-5). Applicant’s arguments are drawn to Nahas failing to teach the new limitations of the claims. However, the new limitations are addressed in the new rejections.
Applicant states that the new claims are allowable for the reasons independent claim 1 is allowable (Remarks pg. 10 last para.). However, this argument was not found to be persuasive, since claim 1 was not found to be allowable over the prior art as explained in the new set of rejections.
Conclusion
No claims are allowed.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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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.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632