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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 14, 2025, has been entered.
Priority
The instant application, U.S. Application Number 18/137,449, filed 21 April 2023 claims priority as a continuation of U.S. Application Number 16/198,811, filed 22 November 2018, which is a continuation of PCT/IL17/50569 filed 22 May 2017, which claims priority from provisional application 62/353,709, filed 23 June 2016 and provisional application 62/339,887, filed 22 May 2016.
Status of the Claims
In the reply filed on Oct. 01, 2024, Applicant has amended claims 1 and 17-18.
Currently, claims 1-20 are under examination on their merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 17, 2025, and Dec. 15, 2025, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Terminal Disclaimer
The terminal disclaimer filed on August 14, 2025, disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of prior patent No. US 10,668109 (Application No. 15/737,290 has been reviewed and is accepted. The terminal disclaimer has been recorded. Thus, the non-provisional rejection of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 18, and 21-24 of U.S. Patent No. 9,833,482 B2 (Application 14/363,814) in view of Reisner et al. (WO 2013093919 A2, 2013, hereafter “Reisner 2013”) is withdrawn due to Applicants filing of Terminal disclaimer.
Withdrawn Objections & Rejections
Rejections and/or objections not reiterated from the previous office action are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 14-15 and 17-18 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.
This rejection is a new rejection.
Regarding the phrase "at least about" renders the claims 14-15 and 17-18 indefinite because the claimed range of the specific kilogram body weight of the subject is already covered by the term “about”. There is nothing in the specification, prosecution or prior art to provide any indication as to the claimed range of “at least about”, thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(b), III.A. It is noted that the specification recites the term “about to be +/- 10%” (see spec., para. 384). For compact prosecution the claim will be interpreted as “about +/- 10%” To overcome this rejection, Applicant may amend the claim to the phrase “at least” or “about.” Appropriate correction is required.
Claim Rejections – 35 USC § 103
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 1-11, 13-15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Reisner et al. (WO2013/084190 A1, published 2013, hereinafter as “Reisner”, cited IDS 5/1/2023), Reisner et al. (WO 2013093919 A2, published 2013, hereafter “Reisner 2013” – prior art of record), Wekerle, et al. ( Transplantation 75.9: 21S-25S, published 2003), Surratt et al. (American Journal of Respiratory and Critical Care Medicine, 2003, hereafter, “Surratt”, cited IDS 6/04/2024), Zuo, Wei, et al. (Nature 517.7536: 616-620, published 2015, cited IDS 5/01/2023), Anversa et al., (US20130216508A1, published 2013, hereinafter as “Anversa,” cited IDS 5/1/2023).
This rejection is a new rejection necessitated by amendments to the claims. However, since it is substantially similar to a rejection set forth in the non-final Official action mailed on March 26, 2025, therefore any aspect of applicant's response considered relevant to the rejection as newly set forth is responded to following the statement of rejection.
Regarding claims 1, 14-15, and 17-18, Reisner discloses a method for treating a pulmonary disorder or injury in a subject in need thereof, including idiopathic pulmonary fibrosis (see e.g. page 3, 7, 28, 30, 72, claim 27-29, 49, 51 fig. 19, 21, 24). Reisner discloses that the method comprises administering to the subject a therapeutically effective amount of a pharmaceutical composition (see e.g. page 26). Reisner discloses that the composition comprises an isolated cell suspension of pulmonary tissue (see e.g. page 72, claim 45, fig. 19, 21, 24) that is non-syngeneic with the subject (see e.g. page 6, claim 45). Reisner discloses that the cell suspension comprises pulmonary tissue cells comprising hematopoietic progenitor (precursor) cells (HPC), epithelial progenitor cells, mesenchymal progenitor cells and endothelial progenitor cells (see e.g. claims 1-7, 21-24, 27, and 33; fig. 19, 21, 24). Reisner also teaches that the cell suspension comprises at least about 0.5×105, 1×105, 0.5×106, 1×106, 1.5×106, 2×106, 2.5×106, 3×106, 3.5×106, 4×106, 4.5×106, 5×106, 5.5×106, 6×106, 6.5×106, 7×106, 7.5×106, 8×106, 8.5×106, 9×106, 9.5×106, 10×106 cells per kilogram body weight of the subject (see e.g. page 36), which overlaps with the range of 1-1000 x 106 cells per Kg body weight of the subject.
In regards to overlapping ranges, MPEP 2144.05(I) states, “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
In the instant case, Reisner discloses that the cell suspension can comprise a heterogeneous population (see e.g. claims 5-7, and 27-28) which, as above, includes both pulmonary tissue cells (i.e. epithelial progenitor cells, mesenchymal progenitor cells and endothelial progenitor cells (see e.g. para. 20, claims 1, 21-23 and 27) and hematopoietic progenitor cells (see e.g. claims 1-6, page 24). As a result, Reisner teaches amounts that overlap with both the amounts of pulmonary tissue cells and hematopoietic cells individually and in combination. Therefore, the cell suspension comprises amounts that include both pulmonary tissue cells and hematopoietic stem cells. As a result, Reisner teaches amounts that overlap with both the amounts of pulmonary tissue cells and hematopoietic cells individually and in combination.
However, in the event that Reisner does not, Reisner 2013 teaches a combination therapy for a stable and long-term engraftment (see e.g. Title and Abstract) comprising transplanting “5-40 x 106 CD34+ hematopoietic stem cells per kilogram body weight into a subject” in need of a non-syngeneic cell or tissue graft (see e.g. page 6-8). Further, Reisner 2013 discloses a range of 5 to 40 x 106 CD34+ hematopoietic stem cells per kilogram body weight overlaps with an amount of 1-1000 x 106 cells per kilogram body weight of the subject. Reisner 2013 also teaches that CD34+ hematopoietic stem cell dose escalation may be used to overcome genetic barriers, enabling satisfactory survival rates following purified haploidentical hematopoietic stem cell transplantation (see e.g. page 1 and 6-8). Further, Reisner 2013 discloses that the cell suspension comprises at least about 0.5×105, 1×105, 0.5×106, 1×106, 1.5×106, 2×106, 2.5×106, 3×106, 3.5×106, 4×106, 4.5×106, 5×106, 5.5×106, 6×106, 6.5×106, 7×106, 7.5×106, 8×106, 8.5×106, 9×106, 9.5×106, 10×106 cells per kilogram body weight of the subject (see e.g. para. 204]), which overlaps with the range of 1-1000 x 106 cells per Kg body weight of the subject.
Accordingly, it would have been obvious to a person of ordinary skill in the arts to combine the method of Reisner and include CD34+ hematopoietic stem cells in a pharmaceutical composition specifically in an amount of 1-1000 x 106 cells per kilogram body weight of the subject because, as taught by the Reisner 2013, it could help overcome genetic barriers and enable satisfactory survival rates following purified haploidentical hematopoietic stem cell transplantation. In regards to overlapping ranges, MPEP 2144.05(I) states, “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”. In the instant case, because Reisner 2013 application teaches that an amount of 1-1000 x 106 cells per kilogram body weight of the subject (specifically, 5 to 40 x 106 CD34+ hematopoietic stem cells per kilogram body weight) is effective to overcome these barriers and treat patients, and because Reisner and Reisner 2013 are in the same technical field of administering non-syngeneic cell or tissue grafts to patients, it could be done with predictable results and a reasonable expectation of success.
Regarding claims 1, Reisner discloses “depending on the type of cells and the disease or condition to be treated, and in order to facilitate engraftment of the isolated population of fetal pulmonary cells, the method may further advantageously comprise conditioning under sublethal, lethal or supra-lethal conditioning prior to administration of the isolated population of cell suspension” (see e.g. page 39). Further, Reisner discloses conditioning a subject using naphthalene and total body irradiation (TBI) induces to eliminate residential lung stem cells (which may proliferate rapidly after naphthalene treatment), prior to administration of the isolated population of fetal pulmonary cells (see e.g. page 40).
Reisner does not explicitly sate wherein the amount of said hematopoietic precursor cells (HPCs) of the pulmonary tissue cells is sufficient to achieve tolerance to said pulmonary tissue cells in the absence of a chronic immunosuppressive regimen of more than 2 weeks and the subject is not treated with said chronic immunosuppressive regimen.
However, Reisner 2013, discloses no post-donor lymphocyte infusions (DLI) immunosuppressive agents will be used (see e.g. page 49, ln. 23). Further, the prior art of Wekerle, et al. discloses hematopoietic stem cell (HSC) transplantation to those who accepted an organ (i.e. lung) leads to a robust form of tolerance (see e.g. abstract, page 21S). Further, Wekerle discloses that HSC transplantation leads to macro-chimerism, which can induce tolerance in humans also comes from patients who had undergone conventional bone marrow transplant for hematologic indications and who subsequently accepted an organ (i.e. lung) from the same donor without long-term immunosuppression (see e.g. page 21S). Additionally, the prior art of Suratt teaches a method whereby allogeneic adult CD34+ HSCs were transplanted into patients (Abstract, p318; Table 1, p319). Suratt also teaches that this resulted in significant rates of epithelial and endothelial chimerism and suggests that adult HSCs could play a therapeutic role in treatment of damaged lungs (Abstract, p318).
Accordingly, it would have been obvious for a person of ordinary skill in the art to combine the method of Reisner with a sufficient amount of hematopoietic precursor cells (HPCs) to achieve tolerance to said pulmonary tissue cells in the absence of a chronic immunosuppressive regimen of more than 2 weeks and the subject is not treated with said chronic immunosuppressive regimen (as taught Reisner 2013, Wekerle and Suratt) because it would lead to chimerism and tolerance leading to better outcomes for patients, which would save time and expenses for their treatments. Furthermore, because Reisner 2013, Surrat, and Wekerle demonstrate the feasibility of these methods, it could be done with predictable results and a reasonable expectation of success. As stated in the specification “the HPCs of the invention induce donor specific tolerance and overcome the need to use a chronic immunosuppressive regimen” (see Spec. page 31). Since Reisner discloses the sufficient amount of pulmonary tissue cells that are to be administered for treating an idiopathic pulmonary fibrosis in a subject ((see e.g. page 3, 7, 28, 30, 72, claim 27-29, 49, 51 fig. 19, 21, 24), it would have been obvious to combine a sufficient amount of hematopoietic stem cells (i.e. hematopoietic precursor cells) to achieve tolerance of said pulmonary tissue cells. A person of ordinary skill in the art would have predictable results with a reasonable expectation of success because Reisner 2013, discloses that no post-donor lymphocyte infusions (DLI) immunosuppressive agents will be used (see e.g. page 49, ln. 23) and Wekerle discloses HSC transplantation leads to a robust form of tolerance (see e.g. abstract, page 21S) with no need of long-term immunosuppressive regimen, and Suratt discloses that HSCs may enhance engraftment and reduce the risk of graft failure (abstract, page 499). Moreover, an artisan of ordinary skill in the art of (hematopoietic stem cells) has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
Reisner does not explicitly teach administering adult pulmonary tissue cells.
However, Reisner discloses that the potential curative role of stem cell-based therapies has been extensively investigated, and that recent findings suggest that early progenitors derived from adult tissues, including umbilical cord and bone marrow, amongst others, can be used to structurally engraft and differentiate as airways, and alveolar epithelial cells, or as vascular endothelial or intestinal lung cells (see e.g. pages 1-2, 11 and Fig. 6). Reisner also teaches that these methods can be used to repair or regenerate injured or diseased lungs (see e.g. pages 1-2, 11 and Fig. 6). Therefore, even though Reisner specifically used fetus-derived pulmonary tissues, Reisner also discloses that it is known in the art that adult (post-natal) tissues can be used for pulmonary therapies as well.
Additionally, the prior art of Zuo teaches a method of transplanting adult distal airway stem cells (see e.g. abstract, p616; p621, Cloning of TBSC and DASC and in vitro differentiation). Zuo also teaches that the adult cells expressed specific epithelial markers (see e.g. page 617, last paragraph column 1 to column 2) that promoted tissue regeneration in the lungs, and that these cells are an attractive model for cell-based therapies for acute and chronic lung diseases (see e.g. abstract, p616; p619, column 2 last paragraph). Further, the prior art of Anversa discloses that it was known that human adult pulmonary tissues comprise a population of lung stem cells (i.e. progenitor cells) that are useful for repair and regeneration of pulmonary damage (see e.g. para. 59-61).
Accordingly, a person of ordinary skill in the arts would be motivated to modify the method Reisner and use adult pulmonary cells (as taught by Zuo and Anversa) because it had been demonstrated in the art that adult pulmonary cells are effective for use in lung cell transplants, and it would save time and expenses to follow known techniques. Further, Zuo teaches that this promoted tissue regeneration in the lungs, and that these cells are an attractive model for cell-based therapies for acute and chronic lung diseases (see e.g. Abstract, p616; p619, column 2 last paragraph). Further, the prior art of Anversa discloses that it was known that human adult pulmonary tissues comprise a population of lung stem cells (i.e. progenitor cells) that are useful for repair and regeneration of pulmonary damage (see e.g. para. 59-61). Moreover, an artisan of ordinary skill in the art of has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007). In the instant case, a person of ordinary skill in the art would have also known that adult tissues are easier to obtain, both because of raw quantities, and because of ethical concerns. Thus, a person of ordinary skill in the arts would be motivated to modify a technique that uses fetal cells, and instead use adult cells, because adult cells would be easier to obtain, which would also save time and expenses. Finally, because Reisner teaches that it is known in the art that adult cells can be used for lung transplants, and because Zuo demonstrates that adult lung pulmonary cells can be effectively transplanted, it could be done with predictable results and a reasonable expectation of success.
Regarding 2, Reisner teaches that the method can comprise conditioning the subject under a sublethal, lethal or supralethal conditioning protocol prior to the administering (see e.g. pages 5, 39, 58-59, 63, and 70-71, claim 29).
Regarding claims 3-4, Reisner also teaches that the conditioning protocol can be a total body irradiation, a partial body irradiation, a chemotherapeutic agent, or an antibody immunotherapy (see e.g. page 39-49, 58, claim 38), which claim 4 indicates are types of reduced intensity conditioning (RIC) as in claim 3.
Regarding claims 5-7, Reisner also teaches conditioning subjects with naphthalene induces site-specific ablation (i.e. damage) of Clara cells in respiratory bronchioles and in broncho-alveolar junctions which facilitates engraftment of the isolated population of fetal pulmonary cells (see e.g. pages 25-27, 39, and 57-58). Reisner continues that subjects can be further treated with total body irradiation (TBI) to effectively eliminate residential lung stem cells which might proliferate rapidly after naphthalene treatment (see e.g. page 39-49, 58, claim 38),
Regarding claims 8, Reisner discloses that the method may comprise treating the subject with an immunosuppressive regimen following transplantation (see e.g. page 38).
Regarding claim 9, Reisner discloses that the immunosuppressive agent may be cyclophosphamide (see e.g. page 38).
Regarding claims 10, Reisner teaches that it may be administered in two doses that it may be administered daily (see e.g. pages 34-36), which implies at least one day, which overlaps with the range of up to two weeks.
Regarding claim 11, as above, Reisner teaches that the method may comprise treating the subject with an immunosuppressive regimen following transplantation and teaches that the immunosuppressive agent may be cyclophosphamide (see e.g. page 33-40). Reisner teaches that it may be administered in one or more doses, which may be daily doses (see e.g. page 40-41).
Reisner is silent in regards to the concentration or timing of the administration of the drug.
However, Reisner 2013 teaches cyclophosphamide in an amount of 25- 200 mg per kilogram body weight (see e.g. claim 1 part b) which overlaps with the range of 50 to 150 mg per kg body weight. Further, Reisner 2013 also teaches that cyclophosphamide on days 3 and 4 post transplantation (see e.g. page 16, line 15-26; Fig. 1A-B; Claim 1a, 34, and 35), and therefore over two doses on days 3 and 4. Additionally, Reisner 2013 also teaches that cyclophosphamide is non-toxic to hematopoietic stem cells and that administration of high dose cyclophosphamide can reduce GVHD, without adverse effects on stem cell engraftment (p2, lines 21-25).
Accordingly, it would have been obvious for a person of ordinary skill in the arts to modify the method of Reisner and treat a subject with the doses and administration as taught by Reisner 2013 because Reisner 2013 teaches that it would reduce GVHD without adverse effects on stem cell engraftment (see e.g. pages 1-3). Further, Reisner 2013 disclose that cyclophosphamide is non-toxic to hematopoietic cells (see e.g. page 32 and 44). Moreover, both Reisner and Reisner 2013 disclose using cyclophosphamide as an immunosuppressive agent. Thus, it could be done with predictable results and a reasonable expectation of success.
Regarding claim 12, Reisner is silent on whether pulmonary cells were expanded ex vivo.
However, Zuo teaches that isolated DASCs were passaged (i.e. expanded) seven times (see e.g. p621, Cloning of TBSC and DASC and in vitro differentiation). While Zuo does not specifically teach that the cells were “expanded”, cells naturally increase in number (and therefore “expand”) over passages. To provide context, “passaging” (also called “subculturing” or “splitting”) is a process whereby a fraction of cells from one culture are transferred to a new vessel with fresh media where they can continue to grow and divide. Additionally, while Zuo does not specifically use the term “ex vivo”, since Zuo teaches that the cells were isolated from organisms and cultured, they were therefore cultured ex vivo or “outside the organism”.
Accordingly, it would have been obvious to one of ordinary skill in the art to modify the method of Reisner and expand the pulmonary tissue as taught by Zuo because Zuo discloses that it would both lead to a greater number of cells that can be used for therapy, reduce the needed number of donor specimen, and therefore save time, expenses, and reduce patient invasion (see e.g. page 621). Thus, it could have been done with predictable results and a reasonable expectation of success. Moreover, an artisan of ordinary skill in the art (i.e. pulmonary tissue cells) of has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
Regarding claim 13, Reisner teaches that the non-syngeneic pulmonary tissue is allogeneic and xenogeneic with respect to the subject (see e.g. page 6, claims 45-46).
Regarding claim 14-15, as above, Reisner also teaches that the isolated population of cell suspension comprises at least about 0.5×105, 1×105, 0.5×106, 1×106, 1.5×106, 2×106, 2.5×106, 3×106, 3.5×106, 4×106, 4.5×106, 5×106, 5.5×106, 6×106, 6.5×106, 7×106, 7.5×106, 8×106, 8.5×106, 9×106, 9.5×106, 10×106 cells per kilogram body weight of the subject (see e.g. page 36) which is close to an amount of at least 100 x 106 cells per kilogram weight of the subject.
In regards to ranges that are close, MPEP 2155.05(I) states, “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)”.
Additionally, a person of ordinary skill in the arts could arrive at an amount of at least 40 x 106 or 100 x 106 cells per kilogram weight of the subject by routine optimization.
In regard to routine optimization, MPEP 2144.05(II)(A) states, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
Accordingly, as stated above, Reisner teaches a broad range of amounts of pulmonary cells that can be used to treat pulmonary disorders, and because the disclosure of the instant application does not point to a criticality in these amounts, it could be done with predictable results and a reasonable expectation of success. Additionally, a person of ordinary skill in the arts would be motivated to use a greater number of cells, as taught by Reisner, because it would be expected to have a greater therapeutic effect, which would lead to better health outcomes for patients. Furthermore, because Reisner teaches that a range of cell amounts can be used in the pharmaceutical composition, it could be done with predictable results and a reasonable expectation of success.
Regarding claim 19, Reisner teaches that the invention can be administered by an intravenous or intratracheal route (see e.g. page 30, claims 31-36).
Regarding claim 20, Reisner teaches that the subject is human (see e.g. claims 1-43).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Response to Traversal:
Applicant assert that Reisner et al. (US 20140356335 A1, cited on IDS 05/01/2023, published 2014; hereafter “Reisner 2014”- prior art of record), Reisner et al. (WO 2013093919 A2, published 2013, hereafter “Reisner 2013” – prior art of record), Badri et al., (Am J Respir Cell Mol Biol;45:809–816, published 2011), Zuo et al. (Nature, 2015, on IDS 05/01/2023 – prior art of record), and Daniele et al. (Blood Transfusion, 2013 – prior art of record) do not teach the claimed invention.
Applicant’s arguments with respect to the previous rejection of claims 1-20 as rejected as being obvious over Reisner et al., Reisner 2013, Badri et al., Zuo et al., and Daniele et al. have been fully considered and are persuasive in view of the amendments to the claims. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Reisner et al. (WO2013/084190 A1, published 2013, hereinafter as “Reisner”, cited IDS 5/1/2023), Reisner et al. (WO 2013093919 A2, published 2013, hereafter “Reisner 2013” – prior art of record), Wekerle, et al. ( Transplantation 75.9: 21S-25S, published 2003), Surratt et al. (American Journal of Respiratory and Critical Care Medicine, 2003, hereafter, “Surratt”, cited IDS 6/04/2024), Zuo, Wei, et al. (Nature 517.7536: 616-620, published 2015, cited IDS 5/01/2023), Anversa et al., (US20130216508A1, published 2013, hereinafter as “Anversa,” cited IDS 5/1/2023).
Applicant argues that Reisner teaches away from using pulmonary adult tissues (Remarks pages 2-4). Applicant argues hindsight reasoning and asserts that the Examiner is picking and choosing from the cited prior art (Remarks, page 3).
Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
In response to applicant's argument, that Reisner represents a teaching away, MPEP §2143.01 notes that, “The court stated that "the prior art's mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed." 391 F.3d at 1200-01, 73 USPQ2d at 1145-46. In the instant case, Reisner discloses “recent findings suggest that early progenitors derived from adult tissues, such as the bone marrow or from the umbilical cord blood, amniotic fluid or placenta, including mesenchymal stem cells, endothelial progenitors or circulating fibrocytes and a variety of other populations, could structurally engraft and differentiate as airways and alveolar epithelial cells or as vascular endothelial or interstitial lung cells and could be utilized in repair and regeneration of injured or diseased lungs " (see e.g. page 1-2, 54, 66). Contrary to Applicants assertion Reisner does not teach away from using adult pulmonary tissues.
In response to applicant's argument that the examiner's conclusion of obviousness 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). In the instant case, the prior art of the prior art of Zuo teaches that the adult cells expressed specific epithelial markers (see e.g. page 617, last paragraph column 1 to column 2) that promoted tissue regeneration in the lungs, and that these cells are an attractive model for cell-based therapies for acute and chronic lung diseases (see e.g. abstract, p616; p619, column 2 last paragraph). Further, the prior art of Anversa discloses that it was known that human adult pulmonary tissues comprise a population of lung stem cells (i.e. progenitor cells) that are useful for repair and regeneration of pulmonary damage (see e.g. para. 59-61). Accordingly, a person of ordinary skill in the arts would be motivated to modify the method Reisner and use adult pulmonary cells (as taught by Zuo and Anversa) because it had been demonstrated in the art that adult pulmonary cells are effective for use in lung cell transplants, and it would save time and expenses to follow known techniques. Moreover, an artisan of ordinary skill in the art of has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
Applicant assert that contrary to the cited prior art, the present application - further evidenced by Milman Krentsis et al. (submitted in response to the Office Action dated June 4, 2024) - demonstrate that adult pulmonary tissue suspensions contain a diverse population of progenitor cells capable of engrafting, differentiating, regenerating functional lung structures and improving fibrosis outcomes in-vivo, without chronic immunosuppression. These findings are directly commensurate with the claimed invention and confirm its efficacy and unexpected advantages over the prior art (Remarks, page 5).
Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a diverse population of progenitor cells capable of engrafting, differentiating, regenerating functional lung structures and improving fibrosis outcomes in-vivo, without chronic immunosuppression) are not recited in the rejected claims. Further, it is noted that Applicant has not pointed to a citation in the reference of Milman Krentsis et al.(2024). Therefore, Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Reisner et al. (WO2013/084190 A1, published 2013, hereinafter as “Reisner”, cited IDS 5/1/2023), Reisner et al. (WO 2013093919 A2, published 2013, hereafter “Reisner 2013” – prior art of record), Wekerle, et al. ( Transplantation 75.9: 21S-25S, published 2003), Surratt et al. (American Journal of Respiratory and Critical Care Medicine, 2003, hereafter, “Surratt”, cited IDS 6/04/2024), Zuo, Wei, et al. (Nature 517.7536: 616-620, published 2015, cited IDS 5/01/2023), Anversa et al., (US20130216508A1, published 2013, hereinafter as “Anversa,” cited IDS 5/1/2023), as applied to claims 1-15 and 17-20 above, and further in view of Daniele et al. (Blood Transfusion, 2013 – prior art of record).
This rejection is a new rejection necessitated by amendments to the claims. However, since it is substantially similar to a rejection set forth in the non-final Official action mailed on March 26, 2025, therefore any aspect of applicant's response considered relevant to the rejection as newly set forth is responded to following the statement of rejection.
The teachings of Reisner et al., apply here as indicated above.
Regarding claim 16, Reisner 2014 does not explicitly teach that cells were depleted of T cells. Further, the prior art of Reisner 2013 teaches that T cells increase the risk of graft-versus-host disease (GVHD) (see e.g. page 2).
However, the prior art of Daniele teaches that graft-versus-host disease (GVHD) is a common complication of allogeneic (which would be “non-syngeneic”) stem cell transplantation and that donor T-cells play a fundamental role in the immunological attack on host tissues in both acute and chronic GVHD (Introduction, paragraphs 01-02), and can manifest as a variety of immune complications such as sclerodermatous skin changes, keratoconjunctivitis, etc. (Introduction, paragraph 04). Daniele further teaches that removal of T-cells from the donor graft (T-cell depletion) offers the possibility of preventing GVHD, and therefore can reduce transplant-related morbidity and mortality (Introduction, paragraph 05-07)). They teach that the probability of acute GVHD after HLA-identical transplantation varied from 25-60% for patients with unmanipulated grafts and 0-35% after T-cell-depleted stem cell transplants (Introduction, paragraph 06). Lastly, Daniele teaches that methods for the depletion of T cells include physical separation techniques (Page 265), immunological techniques (Page 266), and combined immunological/physical methods (Page 267).
Accordingly, it would have been obvious to a person of ordinary skill in the arts to modify the method of Reisner and deplete pulmonary tissue cells of T cells (as taught by Daniele) because it would have improved transplant outcomes for non-syngeneic transplants and reduce the probability of graft versus host disease (GVHD) and other immune transplant-related conditions. Further, Daniele teaches that T cells may be depleted from tissues by a variety of methods. Additionally, Reisner 2013 teaches that T cell-depletion strategies are known in the art (page 1-2, Field and Background of the Invention). Thus, it could have been done with predictable results and a reasonable expectation of success.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Response to Traversal:
Applicant argues that the prior art of Daniele does not remedy the deficiency of the other cited prior art (Remarks, page 5).
Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
The traversal of the other cited prior art is addressed above.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,668,109 B2 in view of Reisner et al. (WO2013/084190 A1, published 2013, hereinafter as “Reisner”, cited IDS 5/1/2023).
This rejection is a new rejection necessitated by amendments to the claims. However, since it is substantially similar to a rejection set forth in the non-final Official action mailed on March 26, 2025, therefore any aspect of applicant's response considered relevant to the rejection as newly set forth is responded to following the statement of rejection.
Although the conflicting claims of U.S. Patent no. US 10,668,109 B2 are not identical to the currently prosecuted claims 1-20, they are not patentable distinct from each other because said claims of both inventions are drawn to transplanting progenitor cells in a suspension from adult lung tissue to a subject in need thereof for treating an inflammatory disease (of which idiopathic pulmonary fibrosis is a type) comprising, administering an agent capable of inducing damage to pulmonary tissue, wherein the damage results in proliferation of resident stem cells.
U.S. Patent no. 10,668,109 does not explicitly teach that the method comprised administering 1-1000 x 106 cells in suspension per Kg body weight of the subject and amount of hematopoietic precursor cells is sufficient to achieve tolerance to said pulmonary tissue cells in the absence of a chronic immunosuppressive regimen of more than 2 weeks and the patient is not treated with said chronic immunosuppressive regimen.
However, Reisner discloses treating idiopathic pulmonary fibrosis (page 28) and teaches a combination therapy for a stable and long-term engraftment (Title, Abstract) comprising transplanting 5 to 40 x 106 CD34+ hematopoietic stem (precursor) cells per kilogram body weight into a subject in need of a non-syngeneic cell or tissue graft (claims 1 and 4).
A range of 5 to 40 x 106 CD34+ hematopoietic stem cells per kilogram body weight overlaps with an amount of at least 1-1000 x 106 cells per kilogram body weight of the subject. Reisner 2013 also teaches that CD34+ hematopoietic stem cell dose escalation may be used to overcome genetic barriers, enabling satisfactory survival rates following purified haploidentical hematopoietic stem cell transplantation (p1, lines 21-24).
Therefore, a person of ordinary skill in the arts would be motivated to modify the method of U.S. patent no. 10,668,109 and include CD34+ hematopoietic stem cells in a pharmaceutical composition specifically in an amount of at least 1-1000 x 106 cells per kilogram body weight of the subject because, as taught by the Reisner 2013, it could help overcome genetic barriers and enable satisfactory survival rates following purified haploidentical hematopoietic stem cell transplantation. Furthermore, because Reisner teaches that an amount of at least 1 x 106 cells per kilogram body weight of the subject (specifically, 5 to 40 x 106 CD34+ hematopoietic stem cells per kilogram body weight) is effective to overcome these barriers and treat patients, and because U.S. Patent no. 10,668,109 and Reisner 2013 are in the same technical field of administering non-syngeneic cell or tissue grafts to patients it could be done with predictable results and a reasonable expectation of success.
In regards to whether the amount of hematopoietic precursor cells is sufficient to achieve tolerance to said pulmonary tissue cells in the absence of a chronic immunosuppressive regimen of more than 2 weeks and the patient is not treated with said chronic immunosuppressive regimen, claims 17 and 18 suggest that amounts of 1 x 105 or 1 x 106 cells per kg body weight of the subject are sufficient to achieve this effect. Therefore, since the method of U.S. Patent no. 10,668,109, as modified by Reisner, teaches administration of hematopoietic precursor cells in these amounts, the reference method is deemed to sufficient to achieve this effect as well.
In regards to obtaining cells from adult cadavers, Reisner teaches that depending on the application and available sources, cell or tissue grafts may be obtained from an adult or cadaver donor (p20, lines 7-9). A person of ordinary skill in the art would have been motivated to use cadaver-derived pulmonary tissue in order to maximize available tissue and cellular donations. Furthermore, because Reisner teaches that the transplanted cellular tissue may be lung (claim 41; p42, lines 10-11), because Reisner teaches that tissue may be derived from adult cadavers (p20, lines 7-9), and because U.S. Patent no. 10,668,109 and Reisner are in the same technical field of administering non-syngeneic cell or tissue grafts to patients, it could have been done with predictable results and a reasonable expectation of success.
Response to Traversal:
Applicant argues that the U.S. Patent No. 10,668,109 B2 as a whole teaches away from the claimed invention (Remarks, page 5). Applicant argues that the ‘109 B2 patent does not teach idiopathic pulmonary fibrosis (ISP) and the use of adult pulmonary tissue (Remarks, page 6).
Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
Contrary to Applicants assertion claim 1 of the ‘109 patent recites “progenitor cells in suspension from an adult lung tissue”(col. 78). Further, claim 8 of the ‘109 patent recites “pulmonary disease” (col. 78). As discussed above, Reisner discloses treating the pulmonary disease of idiopathic pulmonary fibrosis (page 28) and teaches a combination therapy for a stable and long-term engraftment (Title, Abstract) comprising transplanting 5 to 40 x 106 CD34+ hematopoietic stem (precursor) cells per kilogram body weight into a subject in need of a non-syngeneic cell or tissue graft (claims 1 and 4). In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 18, and 17-20 of U.S. Patent No. 10,751368 B2 in view of Reisner et al. (WO2013/084190 A1, published 2013, hereinafter as “Reisner”, cited IDS 5/1/2023).
Although the conflicting claims of U.S. Patent no. US 10,668,109 B2 are not identical to the currently prosecuted claims 1-20, they are not patentable distinct from each other because said claims of both inventions are drawn to transplanting progenitor cells in a suspension from adult lung tissue to a subject in need thereof for treating an inflammatory disease (of which idiopathic pulmonary fibrosis is a type) comprising, administering an agent capable of inducing damage to pulmonary tissue, wherein the damage results in proliferation of resident stem cells.
U.S. Patent no. 10,668,109 does not explicitly teach that the method comprised administering 1-1000 x 106 cells in suspension per Kg body weight of the subject and amount of hematopoietic precursor cells is sufficient to achieve tolerance to said pulmonary tissue cells in the absence of a chronic immunosuppressive regimen of more than 2 weeks and the patient is not treated with said chronic immunosuppressive regimen.
However, Reisner discloses treating idiopathic pulmonary fibrosis (page 28) and teaches a combination therapy for a stable and long-term engraftment (Title, Abstract) comprising transplanting 5 to 40 x 106 CD34+ hematopoietic stem (precursor) cells per kilogram body weight into a subject in need of a non-syngeneic cell or tissue graft (claims 1 and 4).
A range of 5 to 40 x 106 CD34+ hematopoietic stem cells per kilogram body weight overlaps with an amount of at least 1-1000 x 106 cells per kilogram body weight of the subject. Reisner 2013 also teaches that CD34+ hematopoietic stem cell dose escalation may be used to overcome genetic barriers, enabling satisfactory survival rates following purified haploidentical hematopoietic stem cell transplantation (p1, lines 21-24).
Therefore, a person of ordinary skill in the arts would be motivated to modify the method of U.S. patent no. 10,668,109 and include CD34+ hematopoietic stem cells in a pharmaceutical composition specifically in an amount of at least 1-1000 x 106 cells per kilogram body weight of the subject because, as taught by the Reisner 2013, it could help overcome genetic barriers and enable satisfactory survival rates following purified haploidentical hematopoietic stem cell transplantation. Furthermore, because Reisner teaches that an amount of at least 1 x 106 cells per kilogram body weight of the subject (specifically, 5 to 40 x 106 CD34+ hematopoietic stem cells per kilogram body weight) is effective to overcome these barriers and treat patients, and because U.S. Patent no. 10,668,109 and Reisner 2013 are in the same technical field of administering non-syngeneic cell or tissue grafts to patients it could be done with predictable results and a reasonable expectation of success.
In regards to whether the amount of hematopoietic precursor cells is sufficient to achieve tolerance to said pulmonary tissue cells in the absence of a chronic immunosuppressive regimen of more than 2 weeks and the patient is not treated with said chronic immunosuppressive regimen, claims 17 and 18 suggest that amounts of 1 x 105 or 1 x 106 cells per kg body weight of the subject are sufficient to achieve this effect. Therefore, since the method of U.S. Patent no. 10,668,109, as modified by Reisner, teaches administration of hematopoietic precursor cells in these amounts, the reference method is deemed to sufficient to achieve this effect as well.
In regards to obtaining cells from adult cadavers, Reisner teaches that depending on the application and available sources, cell or tissue grafts may be obtained from an adult or cadaver donor (p20, lines 7-9). A person of ordinary skill in the art would have been motivated to use cadaver-derived pulmonary tissue in order to maximize available tissue and cellular donations. Furthermore, because Reisner teaches that the transplanted cellular tissue may be lung (claim 41; p42, lines 10-11), because Reisner teaches that tissue may be derived from adult cadavers (p20, lines 7-9), and because U.S. Patent no. 10,668,109 and Reisner are in the same technical field of administering non-syngeneic cell or tissue grafts to patients, it could have been done with predictable results and a reasonable expectation of success.
Claims 1-5, and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, and 18-19 of U.S. Patent No. 10,933124 B2 in view of Reisner et al. (WO2013/084190 A1, published 2013, hereinafter as “Reisner”, cited IDS 5/1/2023).
Although the conflicting claims of U.S. Patent no. US 10,668,109 B2 are not identical to the currently prosecuted claims 1-20, they are not patentable distinct from each other because said claims of both inventions are drawn to transplanting progenitor cells in a suspension from adult lung tissue to a subject in need thereof for treating an inflammatory disease (of which idiopathic pulmonary fibrosis is a type) comprising, administering an agent capable of inducing damage to pulmonary tissue, wherein the damage results in proliferation of resident stem cells.
U.S. Patent no. 10,668,109 does not explicitly teach that the method comprised administering 1-1000 x 106 cells in suspension per Kg body weight of the subject and amount of hematopoietic precursor cells is sufficient to achieve tolerance to said pulmonary tissue cells in the absence of a chronic immunosuppressive regimen of more than 2 weeks and the patient is not treated with said chronic immunosuppressive regimen.
However, Reisner discloses treating idiopathic pulmonary fibrosis (page 28) and teaches a combination therapy for a stable and long-term engraftment (Title, Abstract) comprising transplanting 5 to 40 x 106 CD34+ hematopoietic stem (precursor) cells per kilogram body weight into a subject in need of a non-syngeneic cell or tissue graft (claims 1 and 4).
A range of 5 to 40 x 106 CD34+ hematopoietic stem cells per kilogram body weight overlaps with an amount of at least 1-1000 x 106 cells per kilogram body weight of the subject. Reisner 2013 also teaches that CD34+ hematopoietic stem cell dose escalation may be used to overcome genetic barriers, enabling satisfactory survival rates following purified haploidentical hematopoietic stem cell transplantation (p1, lines 21-24).
Therefore, a person of ordinary skill in the arts would be motivated to modify the method of U.S. patent no. 10,668,109 and include CD34+ hematopoietic stem cells in a pharmaceutical composition specifically in an amount of at least 1-1000 x 106 cells per kilogram body weight of the subject because, as taught by the Reisner 2013, it could help overcome genetic barriers and enable satisfactory survival rates following purified haploidentical hematopoietic stem cell transplantation. Furthermore, because Reisner teaches that an amount of at least 1 x 106 cells per kilogram body weight of the subject (specifically, 5 to 40 x 106 CD34+ hematopoietic stem cells per kilogram body weight) is effective to overcome these barriers and treat patients, and because U.S. Patent no. 10,668,109 and Reisner 2013 are in the same technical field of administering non-syngeneic cell or tissue grafts to patients it could be done with predictable results and a reasonable expectation of success.
In regards to whether the amount of hematopoietic precursor cells is sufficient to achieve tolerance to said pulmonary tissue cells in the absence of a chronic immunosuppressive regimen of more than 2 weeks and the patient is not treated with said chronic immunosuppressive regimen, claims 17 and 18 suggest that amounts of 1 x 105 or 1 x 106 cells per kg body weight of the subject are sufficient to achieve this effect. Therefore, since the method of U.S. Patent no. 10,668,109, as modified by Reisner, teaches administration of hematopoietic precursor cells in these amounts, the reference method is deemed to sufficient to achieve this effect as well.
In regards to obtaining cells from adult cadavers, Reisner teaches that depending on the application and available sources, cell or tissue grafts may be obtained from an adult or cadaver donor (p20, lines 7-9). A person of ordinary skill in the art would have been motivated to use cadaver-derived pulmonary tissue in order to maximize available tissue and cellular donations. Furthermore, because Reisner teaches that the transplanted cellular tissue may be lung (claim 41; p42, lines 10-11), because Reisner teaches that tissue may be derived from adult cadavers (p20, lines 7-9), and because U.S. Patent no. 10,668,109 and Reisner are in the same technical field of administering non-syngeneic cell or tissue grafts to patients, it could have been done with predictable results and a reasonable expectation of success.
Conclusion
No claim is allowed.
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JOSEPHINE GONZALES
Examiner
Art Unit 1631
/JOSEPHINE GONZALES/ Examiner, Art Unit 1631
/JAMES D SCHULTZ/ Supervisory Patent Examiner, Art Unit 1631