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 .
This action is in response to applicant’s “Remarks”, filed June 22, 2026. The amendments therein have been thoroughly reviewed and entered. Any previous objection/ rejection not repeated herein has been withdrawn.
Applicant's arguments have been thoroughly reviewed but are deemed moot in view of the amendments, withdrawn rejections, and new and/or modified grounds for rejection, necessitated by the amendments, discussed below. Applicant’s instant amendments to claims 50 and 53 has necessitated the new and/or modified ground(s) of rejection presented in this Office action. Also, as a result of in the amendment, the instant application receives the benefit of the earlier filing date under 35 U.S.C. 119 (e) Accordingly, claims 50-56 are entitled to the benefit of the prior application date January 13, 2020. In addition, due to the instant claim amendments the previous drawing objection is withdrawn.
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.
Claim 52 remains rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 52 still includes the term “optionally”, which is indefinite for the reasons delineated in the prior official action, dated Dec. 23, 2025. The examiner again recommend that limitations following “optionally” be presented in new dependent claims.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 50-56 are rejected under 35 U.S.C. 103 as being unpatentable over Aker et al., (US 2004/0110273, hereinafter “Aker”) in view of Cochrum et al., (US 5,876,742, hereinafter “Cochrum”, already of record) in further view of Franklin Jr. et al., (US 2010/0062519, hereafter “Franklin”, already of record).
Regarding claim 50, Akers discloses a culture chamber 10 having a fluid-filled compartment in which cells, tissues and other biologicals are cultured, the compartment 5 being defined at least in part by a molecular weight cut-off membrane 37 secured to a support cylinder 28 and forming a chamber between the membrane and the cylinder (see Fig. 3). The membrane is described as flexible and functions as a semipermeable membrane that defines the culture compartment containing the biologicals and fluid (see para [0045] et seq. and Fig. 3). Akers further discloses that the culture chamber includes a fluid inlet and fluid outlet (see para [0039] et seq.), and that incoming media enters the chamber via the inlet, passes through the membrane into the culture compartment to supply nutrients, and exits via the outlet. This structure corresponds to a culture chamber configured to contain a tissue chamber (the membrane-bounded compartment) and to supply fluid via the inlet and outlet. Akers does specifically disclose the tissue chamber include an alginate solution.
In the related art of tissue transplant (Cochrum-col 4 In 24 et seq.,”[o]ne aspect of the current invention concerns a biological tissue transplant"), Cochrum teaches suspending the tissue in alginate solution (col 5 In 13-14 “[s]uspending and dispersing biological tissue in a solution of soluble alginate") and adding calcium solution or barium solution so the alginate solution gels and encapsulates the tissue (col 5 In 11-23, “capturing the droplets of the biological tissue suspended in alginate of step (a) in a divalent cation solution, such as calcium chloride, barium chloride, or Strontium chloride, to produce gelled spheres wherein the biological tissue is suspended in a gelled primary alginate layer"), the culture chamber being enclosed. Cochrum recognizes that this process of encapsuling the tissue an alginate solution gel extends the viability and longevity of tissue for shipping across long distances (see col 12, ln 21 et seq.) Cochrum discloses a biological tissue core suspended in an alginate solution ("first alginate") which is subsequently gelled with a solution of divalent cations, forming a multilayer alginate coating around the tissue core, to yield a transplant suitable for transplantation. Cochrum therefore teaches that tissue to be transplanted can be contained in an alginate solution, and that this solution can be gelled around the tissue via the introduction of a calcium solution to form an encapsuling gel.
It would have been obvious to a person of ordinary skill in the art (POSITA) at the time of the claimed invention to place the tissue and alginate solution of Cochrum into the membrane bounded culture compartment of Akers (which is designed to hold tissues and fluid), thereby forming a “tissue chamber” partially or fully formed a semipermeable membrane and configured to contain tissue and an alginate solution. This is a straightforward substitution of Cochrum's known tissue/alginate preparation into Akers' known culture chamber for biologicals. The addition of calcium or barium solution through the inlet port so that the alginate solution gels and encapsulates the tissue, gelation occurring within the tissue chamber. Cochrum teaches that the tissue-suspending alginate solution is gelled by contacting it with a solution of divalent cations, such as calcium, there forming a gel coat around the tissue .
Akers teaches that incoming media (nutrient solutions) are introduced through the fluid inlet, pass through the membrane into the culture compartment, and exit through the outlet, thereby supplying solutes to the compartment contents via a semipermeable membrane. Given that Akers explicitly uses its inlet to deliver fluid that passes through the membrane into the culture compartment, and Cochrum teaches delivering divalent cation solutions to gel tissue-suspending alginate, a POSITA would have found it obvious to introduce a calcium or barium solution into the Akers culture chamber via the inlet port, thereby allowing divalent cations to cross the semipermeable membrane and crosslink the alginate solution inside the tissue chamber around the tissue, to obtain in situ encapsulation in the same structure. This is a predictable combination of Akers' known membrane-based nutrient delivery with Cochrum's known ionic crosslinking of alginate.
Akers does not disclose using a transport box or storage container sealed against continuous flow, containing the culture chamber. Franklin discloses a portable organ and tissue preservation and transport apparatus comprising a chamber receiving an organ, a temperature control unit (Franklin- para [0038] et seq.), and means for monitoring and recording temperature (Franklin- para [0043] et seq.) Franklin apparatus is designed to be portable, to minimize spillage, and to maintain substantially sterile and sealed conditions during transport. Franklin's apparatus, including the housing containing the organ chamber and fluid, corresponds to an outer transport box or storage container configured to contain an inner chamber, which is effectively sealed against continuous fluid leakage and environmental exchange.
It would have been obvious to a POSITA to house the Akers culture chamber (with its membrane-bounded tissue chamber and inlet/outlet) inside a portable, sealed transport apparatus such as Franklin's, to allow transport of the cultured/encapsulated tissue under controlled, hypothermic conditions. The motivation for a POSITA to combine Akers' improved culture environment and Cochrum's encapsulated transplant with Franklin's proven portable, temperature-controlled transport technology is to extend viability and enable safe shipping of the transplant. Accordingly, claim 50 is obvious over Akers in view of Cochrum and Franklin.
Regarding claim 51 and 52, the combination of Akers, Cochrum and Franklin teaches the system of claim 50. Specifically, Cochrum teaches wherein the alginate solution is an ultra-purified alginate solution (see col 12, ln 25 et seq., “the alginate solutions contain alginates preferably having mannonate to guluronate moiety ratios of from 1:6 to 6:1, and preferably are free from impurities which would impair the viability and longevity of tissue transplants” which is considered an “ultra-purified alginate solution” in the art.)
Regarding claim 53, the combination of Akers, Cochrum and Franklin teaches the system of claim 50. Specifically, Franklin teaches a temperature sensor disposed in the transport box or the storage container and configured to measure temperature of the culture chamber (see para [0058] “[t]he system monitor registers and records the temperature of the portable casing, chamber, and/or organ through the use of temperature sensors").
Regarding claim 54, the combination of Akers, Cochrum and Franklin teaches the system of claim 50. Specifically, Akers teaches a molecular weight cut-off (MWCO) at about 100kDa (see para [0045] et seq.) The 100kDa MWCO membrane of Akers is designed to permit smaller solutes to cross while retaining large molecules/biological structures, a 100kDa would allow very small species including Ca or Ba ions and ordinary medium components, like that taught by Cochrum, to diffuse across the membrane.
Regarding claim 55, the combination of Akers, Cochrum and Franklin teaches the system of claim 50. Specifically, Franklin teaches a heat insulation component (temperature control unit) configured to maintain the temperature in the transport box, the storage container, and the culture chamber below 10° C. Specially, Franklin discloses at para [0038] “[e]ffective preservation of the organ 15 can be obtained at a variety of temperatures from hypothermic temperature (about 4-10 degrees Centigrade) to standard human body temperature (about 37 degrees Centigrade). The ideal temperature that the organ 15 should be held to maintain over a long period is still being investigated, but there are indications that the ideal temperature should be maintained within a narrow range and the best temperature may be higher than zero degrees Centigrade. Some contemplated temperature ranges for the organ 15 in the embodiments described are 4-6 degrees Centigrade, 10-12 degrees Centigrade and 16-18 degrees Centigrade. Any stated minimum temperature can be associated with any stated maximum temperature that is as great or greater to define a specifically contemplated temperature range.”
Regarding, claim 56, the combination of Akers, Cochrum and Franklin teaches the system of claim 50. Specifically, Franklin teaches a cooling component (temperature control unit 30) configured to maintain the temperature in the transport box, the storage container, and the culture chamber below 10° C. Specially, Franklin discloses at para [0038], [e]ffective preservation of the organ 15 can be obtained at a variety of temperatures from hypothermic temperature (about 4-10 degrees Centigrade) to standard human body temperature (about 37 degrees Centigrade). The ideal temperature that the organ 15 should be held to maintain over a long period is still being investigated, but there are indications that the ideal temperature should be maintained within a narrow range and the best temperature may be higher than zero degrees Centigrade. Some contemplated temperature ranges for the organ 15 in the embodiments described are 4-6 degrees Centigrade, 10-12 degrees Centigrade and 16-18 degrees Centigrade. Any stated minimum temperature can be associated with any stated maximum temperature that is as great or greater to define a specifically contemplated temperature range.
Response to Arguments
Applicant's arguments filed June 22, 2026 have been fully considered but they are not persuasive. In response to applicant’s amendment to claim 50 and 53, which are significant, the previous obvious rejection has been modified as disclosed above. However, in response to applicant's argument that the examiner's conclusion of obviousness in the previous rejection is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As applied above, the proposed combination of Akers, Cochrum and Franklin is based on the express teachings and known functions of the cited art, rather than on applicant’s disclosure. Akers teaches supplying culture medium through an inlet to a membrane-bounded compartment containing biological material for nutrient transfer and waste removal. Cochrum teaches suspending transplant tissue in alginate and exposing the alginate to divalent cations to gel and form an encapsulating coating around the tissue. Franklin teaches housing organ/tissue preservation chambers in a portable, temperature-controlled and temperature-monitored apparatus for transport. A POSIA seeking to preserve and transport viable tissue would have had reason to use Akers’ established inlet/semipermeable-membrane fluid-delivery arrangement to introduce Cochrum’s known gelling ions to a tissue-alginate preparation, and then use Franklin’s known transport enclosure to maintain controlled storage conditions. Each reference is used according to its disclosed function, and the expected result- an encapsulated tissue maintained in a controlled transport environment, which would have been predictable to combine for the reasons delineated above.
Applicant’s disclosure describes tissue preservation using alginate encapsulation and may attribute improved viability, reduced inflammatory-factor release, or extended storage capability to certain embodiments, see specification para [00062]-[00064], [000141]-[000154]. Patentability, however, is determined on the basis of the limitations actually recited in the claims. The pending claims do not require a specified tissue type, a particular measured viability level, a defined reduction in inflammatory factors, a specified culture-medium formulation, or a demonstrated preservation duration relative to a control. As discussed above, the claimed structural components and their stated functions are taught or suggested by the cited art: Akers teaches a membrane-bounded biological culture compartment with inlet/outlet fluid handling; Cochrum teaches divalent-cation gelation of alginate surrounding transplant tissue; and Franklin teaches a temperature-controlled, monitored apparatus for organ/tissue transport. Accordingly, the disclosure’s asserted advantages, without claim limitations requiring them and without comparative evidence establishing unexpected results commensurate in scope with the claims, do not overcome the rejection under 35 U.S.C. 103. Objective evidence, to carry substantial weight, must be shown to have a nexus to the claimed invention.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure include:
a. Roehm et al., (US 2023/0348830) which disclose a bioreactor that includes: a tissue culture chamber; at least one inlet port into the tissue culture chamber; an inlet port member located in each inlet including an inlet tube extending into the tissue culture chamber; at least one outlet port into the tissue culture chamber; an outlet port member located in each outlet including an outlet tube extending into the tissue culture chamber; an optical cover; and a hydrogel can be located in the tissue culture chamber having at least one lumen fluidly coupling the inlet tube to the outlet tube, wherein an inlet interface region of the hydrogel is constrained around the inlet tube and an outlet interface region of the hydrogel is constrained around the outlet tube.
b. Barkai et al., (US 2016/0346431) disclose a system including a plurality of donor cells and a first alginate structure that encapsulates the plurality of donor cells. The first alginate structure has a guluronic acid concentration of between 64% and 74%. The system additionally includes a second alginate structure that surrounds the first alginate structure, the second alginate structure having a mannuronic acid concentration of between 52% and 60%. A selectively-permeable membrane is coupled at least in part to the second alginate structure.
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 P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached between9:30am-7:30 pm EST.
Examiner interviews are available via telephone and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
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/P. Kathryn Wright/Primary Examiner, Art Unit 1798
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