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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09 February 2026 has been entered.
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1-14 and 17 in the reply filed on 02/21/2025 was previously acknowledged.
In the Official Action mailed 26 March 2025, a correction to the claims included in the elected group was made, wherein Group 1 includes claim 30 and claim 17 was removed from the group. Therefore, the elected Group 1 includes claims 1-14 and 30.
Claims 17, 31, 37, 39, and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/21/2025.
Claim Status
Claims 15-16, 18-29, 32-36, 38, 40, and 42-44 were previously cancelled, claim 13 was newly canceled, claims 17, 31, 37, 39, and 41 were previously withdrawn, claims 1-12, 14, 17, 30-31, 37, 39, and 41 are currently amended, claim 45 is new, and claims 1-12, 14, 30, and 45 have been considered on their merits.
Withdrawn Objections/Rejections
The claim rejections under 35 U.S.C. § 101 have been withdrawn due to Applicant’s amendments to the claims. However, a new rejection is set forth below.
The claim rejections under 35 U.S.C. § 102 have been withdrawn due to Applicant’s amendments to the claims. However, a new rejection is set forth below.
The claim rejections under 35 U.S.C. § 103 have been withdrawn due to Applicant’s amendments to the claims. However, a new rejection is set forth below.
Claim Interpretation
The term “apparatus” is not found in the nor defined by the specification, therefore, the term is broadly interpreted as a collection of materials for an intended purpose. In the instant case the ex vivo lymph node and associated vasculature and fluids could read on an ex vivo lymph node apparatus. The term cannulation device is also not defined by the instant specification, thus, reads on any thin tube which facilitates the transfer of fluid. As such, the vessels disclosed in the claim also read on cannulation devices. The “chamber” of claim 1, is defined in the instant specification as “a space in which an intact lobule of an ex vivo lymph node is located” (para. [0052]). This reads as the capsule of the lymph node forms a chamber and the chamber encloses an intact lobule. Therefore, the “chamber” reads as the space inside the capsule of the lymph node which comprises the intact lobule.
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.
Claims 6 and 7 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 6 and 7 both recite the limitation “an external pump” associated with inlet fluid and outlet fluid. It is unclear if this external pump is the same pump or if there are two different pumps. Therefore, the scope of the claim is unclear. For the purpose of compact prosecution, the claim is interpreted as possessing a single pump for the lymphatic fluid and a single pump for the vascular fluid. It is recommended to differentiate the external pumps in the claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-12, 14, 30, and 45 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
This is a new rejection, necessitated by Applicant’s amendments to the claims. A response to applicant’s traversal follows the new rejection below.
The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation.
The claims recite an ex vivo lymph node apparatus comprising an intact lobule, chamber, a lymphatic fluid, a vascular fluid, afferent lymphatic vessel, and an efferent lymphatic vessel wherein the chamber is connected to the vessels via a cannulation device. The high level of generality disclosed in the claims reads on a routine and required step for maintaining an organ ex vivo. The term apparatus, which is not defined nor discussed in the specification, is interpreted to mean the container comprising said ex vivo lymph node, associated vessels and fluid, and a cannulation device. The cannulation device is not defined in the specification, thus, reads on any thin tube, to include arteries and veins, which allows for fluid transfer of the naturally occurring lymphatic fluids, simulating the function and/or providing maintenance of said lymph node. This judicial exception is not integrated into a practical application because an intact lobule, a lymphatic fluid, a vascular fluid, afferent lymphatic vessel, and an efferent lymphatic vessel of a lymph node is not markedly different from an intact lobule, a lymphatic fluid, a vascular fluid, afferent lymphatic vessel, and an efferent lymphatic vessel of a lymph node in vivo and merely placing the lobule in a chamber (container) and connecting the vessels via a cannulation device does not change the structure or function of a naturally occurring lymph node. Placing a natural product in a container and artificially cannulating said product is nothing more than an attempt to generally link the product of nature to a particular technological environment. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because while the ex vivo lymph node apparatus comprising an intact lobule, a lymphatic fluid, a vascular fluid, and afferent lymphatic vessel, and an efferent lymphatic vessel is in a chamber, as explained above does not add a meaningful limitation.
The claims are directed to an ex vivo lymph node apparatus comprising a capsule enclosing an intact lobule in a chamber. The claims are directed to a composition, which is a statutory category of invention (Step 1: YES). The term “chamber”, as defined by the instant specification, is interpreted as a space in which an intact lobule of an ex vivo lymph node is located (para. [0052]). Therefore, the chamber reads as the space provided by the outer membrane of the lymph node, i.e., capsule, and the lobule is enclosed therein.
An ex vivo lymph node is a nature-based product, as such is compared to its closest naturally occurring counterpart to determine if its markedly different from said closest naturally occurring counterpart. The closest naturally occurring counterpart is an in vivo lymph node. The claimed ex vivo lymph node is identical to an in vivo lymph node as the instant specification discloses that the lymph node is obtained from the body (para. [0093]). Thus, there is no marked difference between the claimed product and the naturally occurring counterpart. Thus, the claim recites a product of nature judicial exception. Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are “products of nature” which cannot be patented) (Step 2A, Prong 1: YES).
The claims do not integrate the product into a practical application because the claim is to the product a lymph node, per se, without additional element that utilizes the judicial exception in any application. (Step 2A, Prong 2: NO).
The claims disclose additional elements such as a lymphatic/vascular fluid reservoir, and an external pump (claims 6-7 and 10); an efferent/venous collection (claims 6 and 7); and a cannulation device (claims 1 and 11). These elements are considered well-understood, routine, and conventional as taught by Calle (below) perfusing an organ is a routine and conventional process to maintain the organ/tissue. The new limitation directed to inlet and outlet pressure being controlled by external pumps to simulate physiologic condition (claim 10), describes the purpose of said external pump and is also associated with organ perfusion. Claim 30 discloses a method of using the lymph node of claim 1 by perfusing the intact lobule with lymphatic and vascular fluid. Claim 45 recites components which are presented in the alternative and would be found in naturally occurring in a lymph node or lymphatic fluid. The claim also discloses cell culture media or pharmaceutical test agents. Cell culture media nor pharmaceutical test agents are defined by the claim nor specification and both could be considered a nature-based product or a naturally occurring substance found in a lymph node or lymphatic fluids, such as naturally occurring nutrient (cell culture media) and serum or metabolites (pharmaceutical test agent). Since the claim does not define the media nor test agent characteristics they are also considered to be a judicial exception as it is considered a naturally occurring substance without markedly different characteristics. These elements recite an artificial lymphatic system wherein the fluids are perfused through the intact lobule through vessels which are a natural part of the lymph node. The difference would be the presumed presence of an external pumping mechanism, however, the limitations of the claims merely recite an artificial means to use the lymph node as it was intended to be used or a means to preserve the ex vivo organ by means of perfusion which is nothing more than an attempt to generally link the product of nature to a particular technological environment using well-understood, routine, and conventional methods. See MPEP § 2106.05(d) and (e). Therefore, there are no additional elements that add significantly more to the judicial exception. (Step 2B: NO).
Claims 2-12, 14, 30, and 45, which depend from claim 1, do not include additional elements which are sufficient to integrate into a practical application or to amount to significantly more than the judicial exception as the claimed limitations all refer to endogenous components which would naturally be a part of in intact lobule of a lymph node or components to preserve and/or use said lymph node.
The wherein clause of claim 5 directed towards perfusing the intact lobule with lymphatic fluid, does not add structure to the claimed ex vivo lymph node, as such, is not limiting.
Therefore, claims 1-12, 14, 30, and 45 do not include eligible subject matter and the claims are rejected.
Response to Traversal
Applicant's arguments filed 09 February 2026 have been fully considered but they are not persuasive.
Regarding the arguments directed to the 101 rejections, these arguments are merely the argument of counsel and is unsupported by evidence or declarations of those skilled in the art. The comments directed to the 101 rejection restate the newly amended claim 1 and additionally states, Applicant disagrees and the claims recite significantly more than a natural product, with no further discussion. Attorney argument is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection. See M.P.E.P. § 2129 and § 2144.03 for a discussion of admissions as prior art. Counsel's arguments cannot take the place of objective evidence. In re Schulze, 145 USPQ 716 (CCPA 1965); In re Cole, 140 USPQ 230 (CCPA 1964); and especially In re Langer, 183 USPQ 288 (CCPA 1974). See M.P.E.P. § 716.01(c) for examples of attorney statements that are not evidence and that must be supported by an appropriate affidavit or declaration.
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.
Claims 1-12, 14, 30, and 45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tobbia et al. (Plast. Reconstr. Surg, 2009, of record).
This is a new rejection, necessitated by Applicant’s amendments to the claims. A response to Applicant’s traversal follows the new rejection below.
Regarding claims 1 and 11, Tobbia teaches transplantation of an autologous lymph node (Abstract). Tobbia teaches recipient vessels comprising the lateral saphenous vein (2 to 4 mm), the medial circumflex femoral artery (1 to 3 mm) and, to a lesser degree, the caudal femoral artery (1 to 2 mm) were exposed and the transplant vessels approximated to these vessels with bridging micro clamps (p. 778, Nodectomy Followed by Lymph Node Transplant by Microvascular Anastomosis). This reads as the intact lobule retains viable endogenous artery and vein each attached to the intact lobule when the lobule is removed from a donor. Tobbia teaches successful lymphatic function and lymph node health after transplantation (p. 781 and Fig. 3). This implies the presence of the afferent and efferent lymphatic vessels, as lymphatic function would not be possible without lymphatic vessels. The lymph node removed from the donor would inherently retain viable endogenous cells, as evidenced by the lymph node health and function post transplantation (Fig. 2).
Tobbia teaches replacement of the excised (ex vivo) lymph node with a vascularized lymph node transplant resulting in lymph transport (p. 780, Results, 2nd column). Thus, the transplanted lymph node reads on the limitations of the claim, as the ex vivo lymph node comprises its vasculature and the animal comprising the transplanted lymph node reads as the apparatus which Tobbia demonstrated perfuses the intact lobule via the endogenous vasculature. Based on the interpretation of the claim, as set forth above, the cannulation device reads on the endogenous vasculature of the animal hosting the transplanted lymph node.
Regarding claims 2 and 3, the vascularized node of Tobbia is intact which would inherently contain all endogenous features of a lymph node, to include the endogenous capsule (claim 2), sinus adjacent to the intact lobule (claim 3).
Regarding claim 4, the wherein clause “wherein at least 80% of the endogenous cells remain viable for at least 24 hours after the intact lobule is removed from the donor” is considered an inherent property of the lymph node removed from the donor. As Tobbia teaches the same lymph node was excised from a donor, it is expected that the lymph node of Tobbia would have the same property as claimed.
Regarding claim 5, the wherein clause directed to perfusing lymphatic and vascular fluid for at least 30 minutes reads as an intended use of the claimed ex vivo lymph node apparatus (product). Intended use statements are not limiting because they do not add structure to the product. It has been held that when the body of a claim fully and intrinsically sets forth all limitations of the claimed invention, such as all the components of a composition, and the preamble merely states the intended use of the invention, rather than any distinct definition of the any of the claimed invention’s limitations, the preamble is not considered a limitation and is of no significance to claim construction. See MPEP § 2111.02.
Regarding claims 6 and 7, Tobbia teaches replacement of the excised (ex vivo) lymph node with a vascularized lymph node transplant resulting in lymph transport (p. 780, Results, 2nd column). The ex vivo lymph node necessarily comprises its vasculature and the animal comprising the transplanted lymph node reads as the apparatus which Tobbia demonstrated perfuses the intact lobule via the endogenous vasculature. The recipient animal reads on an external pump as the animal is pumping lymphatic fluid and vascular fluid into and out of said transplanted lymph node, which would replenish the animal’s lymphatic and vascular system of said fluids. Therefore, the animal’s lymphatic and vascular systems reads on the claimed reservoirs.
Regarding claims 8 and 9, in the biological system presented by Tobbia, it is understood that the transplanted lymph node would control lymphatic and vascular inlet pressure.
Regarding claim 10, the recipient animal’s lymphatic and vascular pumping systems would control said pressures and simulate the physiological conditions of the donor animal.
Regarding claim 12, Tobbia teaches recipient vessels comprising the lateral saphenous vein, medial circumflex femoral artery, and caudal femoral artery were exposed and the transplant vessels approximated to these vessels with micro clamps wherein the vessels were sutured together microsurgically in an end-to-end fashion (p. 778, 1st column). The arteries of the recipient animal read as endogenous arteries are attached to the intact lobule as Tobbia teaches transplantation of autologous lymph nodes. Regarding the limitation directed to the donor, it is understood that the donor arteries would be closed off as they are no longer attached to said excised lymph node.
Regarding claim 14, the endogenous cells of a lymph node would inherently be present in an ex vivo lymph node, therefore, the lymph node taught by Tobbia teaches these limitations.
Regarding claim 30, the claim recites a product-by-process limitation. Product-by-process limitations are considered only in as far as the method of production imparts distinct structural or chemical characteristics or properties to the product. Therefore, if the product, as claimed, is the same or obvious over a product of the prior art (i.e., is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. See MPEP 2113. Therefore, claim 30 reads as an ex vivo lymph node apparatus which is taught by Tobbia as indicated above.
Regarding claim 45, the lymph node removed from the donor of Tobbia would inherently retain viable endogenous lymphatic fluid, cells, lymphocytes, proteins, and lipids, as evidenced by the lymph node health and function post transplantation (Fig. 2). The limitations of the claim are presented in the alternative; thus, all of the optional limitations are not required.
Thus, the reference anticipates the subject matter of claims 1-12, 14, 30, and 45.
Response to Traversal
Applicant’s arguments filed 09 February 2026 have been fully considered but they are not persuasive.
In response to Applicant's argument, directed to the previous rejection under 102, that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., The chamber encompasses an intact lobule, a lymphatic fluid, a vascular fluid, an afferent lymphatic vessel, and an efferent lymphatic vessel.) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding the newly added limitations “apparatus” and “via a cannulation device”, based on the broadest reasonable interpretation of the claims, these limitations are taught by Tobbia as discussed in the new rejection set forth above.
Claim Rejections - 35 USC § 103
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 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 1-12, 14, 30, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Tobbia et al. (Plast. Reconstr. Surg, 2009, of record) and in view of Calle et al. (US 2019/0201453 A1, published 07/04/2019, IDS ref., of record) as evidenced by Semeraro (J. Anat. (1986), IDS ref., of record).
This is a new rejection, necessitated by Applicant’s amendments to the claims. A response to applicant’s traversal follows the new rejection below.
Based on the claim interpretation above, the ex vivo lymph node of Tobbia reads on an ex vivo lymph node apparatus. However, if the claim was interpreted to encompass an ex vivo lymph node in a non-biological container, Tobbia is silent to a non-biological container comprising an ex vivo lymph node which is perfused by an external mechanical pumping action.
Regarding claims 1 and 11, Tobbia teaches transplantation of an autologous lymph node (Abstract). Tobbia teaches recipient vessels comprising the lateral saphenous vein (2 to 4 mm), the medial circumflex femoral artery (1 to 3 mm) and, to a lesser degree, the caudal femoral artery (1 to 2 mm) were exposed and the transplant vessels approximated to these vessels with bridging micro clamps (p. 778, Nodectomy Followed by Lymph Node Transplant by Microvascular Anastomosis). This reads as the intact lobule retains viable endogenous artery and vein each attached to the intact lobule when the lobule is removed from a donor. Tobbia teaches replacement of the excised (ex vivo) lymph node with a vascularized lymph node transplant resulting in lymph transport (p. 780, Results, 2nd column). Tobbia teaches successful lymphatic function and lymph node health after transplantation (p. 781 and Fig. 3). This implies the presence of the afferent and efferent lymphatic vessels, as lymphatic function would not be possible without lymphatic vessels. The lymph node removed from the donor would inherently retain viable endogenous cells, as evidenced by the lymph node health and function post transplantation (Fig. 2).
Tobbia is silent to a non-biological container comprising an ex vivo lymph node, wherein the lymphatic vessels are connected via a cannulation device which is perfused by an external mechanical pumping action.
However, Calle teaches the method of obtaining intact lobes from rodent lungs having endogenous cells, attached artery and vein, and capacity to perfuse cells and/or vascular liquid (para. [0012] and [0310-0321]). Calle teaches a bioreactor is capable of ventilating lungs via negative pressure as well as providing vascular perfusion and ventilation at physiologic rates and pressures (para. [0097]). The bioreactor of Calle reads as an apparatus. Calle teaches the bioreactor includes at least one cannulation device, a perfusion apparatus for perfusing media through the cannula, and means (e.g., a containment system) to maintain a sterile environment for the organ (para. [0164]). Thus, the bioreactor of Calle reads as an apparatus comprising a cannulation device wherein vascular fluid is perfused into and out of the intact lobule.
Therefore, it would have been obvious to one of ordinary skill in the art to utilize the bioreactor of Calle with the ex vivo lymph node of Tobbia with a reasonable expectation of success because Calle teaches methods of maintaining intact lobes obtained from rodent lung with intact vascular network containing endogenous cells and further providing vascular perfusion via the pulmonary artery or vein and Calle demonstrates the ability of a bioreactor to maintain viable organs ex vivo. One would have been motivated to utilize the bioreactor of Calle with the ex vivo lymph node of Tobbia because the ex vivo lymph node would require perfusion to maintain viability and the apparatus comprising said ex vivo lymph node could be utilized studying developmental biology or drug discovery. Thus, Tobbia in view of Calle render obvious the ex vivo lymph node apparatus as claimed.
Regarding claims 2 and 3, the vascularized node of Tobbia is intact which would inherently contain all endogenous features of a lymph node, to include the endogenous capsule (claim 2), sinus adjacent to the intact lobule (claim 3).
Regarding claim 4, the wherein clause “wherein at least 80% of the endogenous cells remain viable for at least 24 hours after the intact lobule is removed from the donor” is considered an inherent property of the lymph node removed from the donor. As Tobbia teaches the same lymph node was excised from a donor, it is expected that the lymph node of Tobbia would have the same property as claimed.
Regarding claim 5, the wherein clause directed to perfusing lymphatic and vascular fluid for at least 30 minutes reads as an intended use of the claimed ex vivo lymph node apparatus (product). Intended use statements are not limiting because they do not add structure to the product. It has been held that when the body of a claim fully and intrinsically sets forth all limitations of the claimed invention, such as all the components of a composition, and the preamble merely states the intended use of the invention, rather than any distinct definition of the any of the claimed invention’s limitations, the preamble is not considered a limitation and is of no significance to claim construction. See MPEP § 2111.02.
Regarding claims 6 and 7, Tobbia teaches replacement of the excised (ex vivo) lymph node with a vascularized lymph node transplant resulting in lymph transport (p. 780, Results, 2nd column). The ex vivo lymph node would necessarily comprise its vasculature and the bioreactor of Calle reads on the lymphatic and vascular fluid reservoirs and external pumps. Therefore, Tobbia in view of Calle render obvious the limitations of the claims.
Regarding claims 8, 9, and 10, Calle teaches the bioreactor is capable of providing vascular perfusion at physiological rates and pressures (claim 10); thus, would control lymphatic and vascular inlet pressure. Therefore, Tobbia in view of Calle read on the limitations of the claims.
Regarding claim 12, directed to an additional endogenous artery is attached to the intact lobule when the intact lobule is removed from the donor and closed off. This clause is a matter of routing optimization, see MPEP § 2144.05 (II)(A). It is known in the art lymph nodes can be connected to more than one artery as evidenced by Semeraro who discloses inguinal human lymph nodes typically have one artery while mesenteric human lymph nodes have multiple arteries (Table 1). If additional endogenous arteries were present when the intact lobule was removed, it would be obvious to close off said additional artery in order to effectively control the perfusion of the vascular fluid.
Regarding claim 14, the endogenous cells of a lymph node would inherently be present in an ex vivo lymph node, therefore, the lymph node taught by Tobbia teaches these limitations.
Regarding claim 30, the claim recites a product-by-process limitation. Product-by-process limitations are considered only in as far as the method of production imparts distinct structural or chemical characteristics or properties to the product. Therefore, if the product, as claimed, is the same or obvious over a product of the prior art (i.e., is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. See MPEP 2113. Therefore, claim 30 reads as an ex vivo lymph node apparatus, which was rendered obvious by Tobbia in view of Calle as indicated above.
Regarding claim 45, the lymph node removed from the donor of Tobbia would inherently retain viable endogenous lymphatic fluid, cells, lymphocytes, proteins, and/or lipids, as evidenced by the lymph node health and function post transplantation (Fig. 2). The limitations of the claim are presented in the alternative; thus, all of the optional limitations are not required.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Response to Traversal
Applicant's arguments filed 09 February 2026 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that Calle does not cure the deficiencies of Tobbia, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). As such, the references have been shown to render obvious the limitations of the claims, as indicated above; thus, the references utilized are shown to not be deficient.
Additionally, Applicant argues Calle teaches away from an intact lobule that retains viable endogenous cells in the intact lobule in vivo, as recited in claim 1. Calle does teach decellularized tissue to be utilized as a matrix which supports cellular growth, however, Calle was introduced to demonstrate the obviousness of a perfusion device and maintaining an ex vivo organ, not the lymph node itself. It was reasonable to conceive the perfusion device would be capable of maintaining any ex vivo organ. Therefore, the arguments directed to Calle are not persuasive.
Conclusion
No claims are allowed.
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/N.A.H./Examiner, Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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