DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
The amendment of 06/26/2025 has been entered. Claims 1-6, 8-16, and 18-21 are currently pending in this US patent application and were examined on their merits.
Withdrawn Rejections
All rejections of claims 7 and 17 set forth in the previous Office action are withdrawn in light of the amendment of 06/26/2025, which canceled these claims.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-6, 8-16, and 18-21 remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cypel et al., Science Translational Medicine 1(4): 4ra9 (2009), in view of US patent 6328960 granted to McIntosh et al., issued 12/11/2001, and Ingemansson et al., Ann. Thorac. Surg. 87: 255-260 (2009).
Cypel teaches subjecting pig lungs and injured human donor lungs to a perfusion protocol in which the lungs were perfused with an acellular perfusate of Steen solution and an adenoviral vector (serotype 5) encoding IL-10 under the control of a cytomegalovirus promoter was provided via intra-airway delivery (see entire document, including page 2, left column, paragraph 1, to page 3, right column, paragraph 1; page 6, right column, paragraph 4; page 7, left column, paragraph 2; cf. claims 1-5, 11-15, and 21; the Examiner notes that perfusing the lungs with Steen solution would inherently result in the lungs containing a “substantially bloodless perfusate” as recited in instant claim 1; the Examiner further notes that claims 11 and 21 recite limitations of the lung from which the recited lung was repaired, but there is no requirement in the claims that any particular characteristics of the pre-repair lung be maintained in the claimed lung, and so claims 11 and 21 appear to be equivalent to claim 1). The IL-10 gene therapy resulted in increased IL-10 levels in the lungs, as well as a reduction in the levels of IL-6 and IL-1β (page 3, Figure 2; cf. claims 2-6 and 12-16). The lungs were then transplanted into recipients (page 6, right column, paragraph 1). The ex vivo AdhIL-10 treatment led to improved lung function and inhibition of inflammation before and after transplantation (page 5, left column, paragraph 2; cf. claims 6, 10, 16, and 20; the Examiner notes that, because the IL-10 gene therapy reduces inflammation, the IL-10 can be interpreted as an “anti-inflammatory agent” as recited in instant claims 10 and 20). The perfusion with AdhIL-10 resulted in significantly improved lung oxygenation and reduced pulmonary vascular resistance (page 3, right column, paragraph 2; cf. claims 1, 8-9, and 18-19).
However, Cypel does not teach that the lungs contain stem cells that do not come from the lung donor or one of the particular perfusate ingredients recited in instant claim 1.
McIntosh teaches methods of preventing, reducing, or treating transplant rejection (see entire document, including column 1, lines 15-17). In one embodiment, the donated organ includes mesenchymal stem cells (MSCs) obtained from a third party (i.e., neither the donor nor the recipient of the organ) to ameliorate an immune response by the recipient’s T cells against the foreign tissue when it is transplanted (column 3, lines 6-15; cf. claim 1 [“…exogenous stem cells that ameliorate injury or inflammation in the ex vivo lung…wherein the exogenous stem cells are from a source other than the human donor and a source other than the human recipient”]; the Examiner notes that ameliorating an immune response following transplant qualifies as “[ameliorating] injury…in the ex vivo lung”). The MSCs may be allogeneic (column 2, lines 17-20) and may come from a human (column 2, lines 65-66), indicating that the donor organ is human, i.e., comes from a different member of the same species as the MSCs (cf. claim 1 [“…wherein the lung is from a human donor”]). The donor organ can be a lung (column 5, lines 4-6; cf. claim 1 [“…wherein the lung is from a human donor and the exogenous stem cells are from a source other than the donor and a source other than the recipient”]).
Ingemansson teaches the ex vivo reconditioning of human donor lungs by perfusing them with Steen solution containing heparin (see entire document, including page 256, right column, paragraph 2; cf. claim 1).
While Cypel does not teach that the lungs treated with perfusion and IL-10 gene therapy prior to transplantation into recipients were also treated with MSCs, it would have been obvious to one of ordinary skill in the art to do so because McIntosh teaches that treating donor organs with MSCs prior to transplantation into the recipient can ameliorate the immune response of the recipient to the transplanted tissue. While Cypel and McIntosh do not teach that heparin is included in the perfusate in the lungs rendered obvious by their teachings, it would have been obvious to one of ordinary skill in the art to include heparin in the perfusate because Ingemansson teaches that heparin is a useful ingredient to add to Steen solution when perfusing a donor lung to recondition it. One of ordinary skill in the art would have a reasonable expectation that treating the lung of Cypel with the MSCs of McIntosh and the heparin of Ingemansson prior to transplantation would successfully result in the amelioration of the immune response of the recipient to the donated lung.
Therefore, claims 1-6, 8-16, and 18-21 are rendered obvious by Cypel in view of McIntosh and Ingemansson and are rejected under 35 U.S.C. 103(a).
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 8-16, and 18-21 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11425900. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘900 recite a lung that is narrower than the instantly recited lung. As such, the instant claims are ‘anticipated’ by the cited claims of ‘900 and are rejected on the ground of nonstatutory double patenting.
Claims 1-6, 8-16, and 18-21 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11771081. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘081 recite a lung that is narrower than the instantly recited lung. As such, the instant claims are ‘anticipated’ by the cited claims of ‘081 and are rejected on the ground of nonstatutory double patenting.
Response to Arguments
Applicant has traversed the above rejection of the claims under 35 U.S.C. 103(a) as being unpatentable over Cypel in view of McIntosh and Ingemansson. Applicant states that the cited references do not teach a lung that comprises the stable pulmonary vascular resistance, dynamic compliance, and peak respiratory pressure recited in amended claim 1 (remarks, pages 5-6). This argument has been fully considered but has not been found persuasive.
The Examiner notes that the instant claims do not require any particular level of stability or that the recited values be stable for any particular length of time. As such, any stability in these parameters for any length of time, including the smallest fraction of a second, is sufficient to satisfy the claims as currently drafted.
Applicant states that McIntosh does not teach a lung that has been repaired for transplantation into a donor and is, instead, concerned with suppressing the immune system of a recipient (remarks, page 5). This argument has been fully considered but has not been found 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). The Examiner notes that Cypel teaches a lung that is repaired for transplantation and that the teachings of McIntosh are certainly relevant to the art of organ transplantation.
Applicant states that Ingemansson teaches the use of a perfusate comprising heparin but does not teach the use of a perfusate that comprises methylprednisolone, cilastatin and imipenem, and/or heparin (remarks, pages 5-6; emphasis added). This argument has been fully considered but has not been found persuasive because Applicant has clearly noted on the record that Ingemansson’s perfusate contains heparin, and so Ingemansson’s perfusate clearly contains one of the instantly recited ingredients, which is all that is necessary to satisfy the claim given that the instantly claimed list of ingredients requires only one ingredient because of the recitation of ‘and/or’.
Therefore, the Examiner has maintained the rejections presented above.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached on Monday-Friday, 7:30-5:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau, can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Erin M. Bowers/
Primary Examiner, Art Unit 1653
09/08/2025