DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicants’ amendments to the claims and arguments filed on June 25, 2026, have been received and entered. Claims 1-32, 40-50 have been canceled, while claims 33-34, 36, 38-39 have been amended. Claims 51-58 are newly added. Claims 33-39, 51-57 and 58 are pending in the instant application.
Election/Restrictions
Applicant’s election of claims 33-39 (group II) in the reply filed on November 17, 2025, was acknowledged. Because applicants did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Priority
This application is 371 of PCT/US2021/062007 filed on 12/06/2021, which claims priority from US provisional application no 63/122,416 filed on 12/07/2020.
Claims 33-39, 51-58 are under consideration.
Withdrawn- Claim Rejections - 35 USC § 112
Claim34 was 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. Applicants’ amendment to claim 34 obviates the basis of the rejection.
Maintained & New-Claim Rejections - 35 USC § 103-in modified form
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.
Claims 33, 35-39 remain and claims 51-58 rejected under 35 U.S.C. 103 as being unpatentable over Keck (US20180187210, dated 7/5/2018), Wahl (Nat Biotechnology. 2019 Oct;37(10):1163-1173, 8/26/2019) as evidenced by Wu (PLoS Pathog 2017, 13(4): e1006281, 1-24).
Claims are directed to a method comprising: administering to an immunodeficient mouse cells of a human patient-derived xenograft (PDX), wherein the cells comprise a virus entry moiety; and administering to the immunodeficient mouse a virus comprising a surface moiety that binds to the pathogen entry moiety.
With respect to claim 33, 58, Keck teaches a method comprising
(i) administering to a humanized NSG immunodeficient mouse, a cancer cell from a human patient-derived xenograft (PDX). (para 25, 155, 159), wherein PDX is tumor of a lung, colon, bladder or ovarian cancer (see para. 22-23).
Regarding claims 35, Keck teaches the administering is by tail vein injection, subcutaneous, cardiac injection, caudal artery injection, cranial injection, hepatic artery injection (see para. 107).
With respect to claim 36-37, Keck teaches a method further comprising administering to the mouse a therapeutic agent cisplatin to assess the toxicity of the agent showing reduction in tumor (see para. 184, 193-194). It is further disclosed that engrafted tumors appear to evade human immunity much as they do in the patients from which they were derived. Moreover, treatment with a TIL check-point inhibitor presumably releases T-cells from anergy and stimulates their cytotoxicity towards the tumor (see para. 206).
Regarding claims 54-56, Keck teaches that humanized mouse has a NOD genotype whose genome comprises a null mutation in a murine Prkdc gene and murine IL2rg (NOD.Cg-Prkdc. scid Il2rg.tm1Wjl/SzJ (see para. 11).
Keck teaches humanized mouse models would permit human-specific infections and therapies, thus enabling clinically relevant in vivo studies of human cells, tissues, and immune systems (see para. 6, 158). Keck differs from claimed invention by not disclosing administering to the immune-deficient mouse a virus to the cells comprises a virus entry moiety and a virus comprising a surface moiety that binds to the pathogen entry moiety.
Wahl cure the deficiency by disclosing transplanting a humanized immunocompromised mouse with ectopically transplanted human lung tissue and human immune cells via bone marrow transplantation to study the infection of respiratory viruses (see fig. 1). It is further disclosed that Middle East respiratory syndrome coronavirus MERS-CoV (a respiratory virus) or HCMV or Zika virus (flavivirus) is inoculated directly into the human lung implants (See abstract page 1164, col. 1, last para, col. 2, para. 2 and 5) (limitation of 33, 51-52).
Regarding claims 36-38, Wahl teach administering ganciclovir (GCV) to said immunodeficient mouse to treat or prevent infection by HCMV (see page 1164, col. 2, last para.).
With respect to claim 39, Wahl teaches method further comprising assessing viral load in the mouse (see page 1161, col. 1, last para to col. 2, para. 1., fig. 2).
The combination of reference does not specifically recite inherent feature of virus to the cells comprise a virus entry moiety and a virus comprising a surface moiety that binds to the pathogen entry moiety.
However, before the effective filing date of instant application, it was known in prior art that PDGFR-α functions as an entry receptor tor for HCMV expressing gH/gL/gO (see abstract) (limitation of claim 53. It is further disclosed that gH/gL/gO—PDGFR-αinteraction starts the predominant entry pathway for infection of the lung fibroblasts (see Wu et al abstract and page 3).
Therefore, it would have been prima facie obvious for a person of ordinary skill in art to combine the teachings of prior art modify the method of Keck by administering a virus as suggested by Wahl, in the method of evaluating lung function following viral infection, with a reasonable expectation of success, at the time of the instant invention. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to do so because humanized mouse models disclosed in prior art is reported to support infection and replication of important human viral pathogens that could be used to study human pathogens that target the lung (for example, enterovirus, adenovirus type 7, influenza virus, rhinovirus and metapneumovirus), accelerating the in vivo testing of preventative and therapeutic approaches for potential agents (see page 1171, col. 2, last para.). Other limitations of lung cells comprise a pathogen entry moiety and virus comprising a surface moiety that binds to the viral entry moiety would be inherent in view of the teaching of Wu. One of skill in the art would have been expected to have a reasonable expectation of success in infecting the lung cells derived from xenograft because prior art teaches the successful infection with virus comprising coat glycoprotein that binds to surface receptor on the surface of the lung cells as evident from the teaching Wahl in view of Wu . It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf).
Claims 33, 34 remain rejected under 35 U.S.C. 103 as being unpatentable over Keck (US20180187210, dated 7/5/2018), Wahl (Nat Biotechnology. 2019 Oct;37(10):1163-1173, 8/26/2019) as evidenced by Wu (PLoS Pathog 2017, 13(4): e1006281, 1-24) as applied above and further in view of Xian (WO2014152321, 9/21/2014). Claim interpretation: Claim 39 is interpreted as wherein the cells are administered sample of the single cell suspension.
The teaching of Keck, Wahl and Wu have been described above and relied in same manner here. The combination of references differs from claimed invention by not disclosing wherein the cells are administered sample of the single cell suspension.
Xian teaches picking a single colony to develop a pedigree cell line, where cell line has been derived from a single cell (page 125, first paragraph; page 131 third paragraph to last paragraph). It is further disclosed that the administered sample of the single cell suspension is delivered by pipetting (page 131, last paragraph; parage 133, last paragraph).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to combine the teachings of prior art modify the method of Keck and Wahl by administering the cells are sample of the single cell that are suspension is delivered by pipetting, as suggested by Xian, in the method of evaluating lung function following viral infection, with a reasonable expectation of success, at the time of the instant invention. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to do so because it provides evaluation of therapeutics in a sample derived from a single cell clone. One of skill in the art would have been expected to have a reasonable expectation of success in infecting the lung cells derived from xenograft because prior art teaches the successful infection with virus comprising coat glycoprotein that binds to surface receptor on the surface of the lung cells as evident from the teaching Wahl in view of Wu . It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf).
Response to arguments
Applicants disagree with the rejection arguing that the claimed method is based, in part, on the recognition by the inventor that cancerous tissues from human PDXs possess unique host genetic profiles that are useful in, e.g., interrogating the genetic underpinnings of susceptibility to infection and disease progression. For instance, if a new variant of a known virus or a new virus is identified, the claimed mouse models can be used to determine which receptor is used for infection of humans. Human PDXs are rich with genetic heterogeneity and complexity, each with its own unique genetic profile heterogeneity/complexity is illustrated in Table 2 of the instant application, reproduced below, which demonstrates varying expression levels of ACE2, CD147, and TMPRSS2 across 24 different cancerous human PDX samples. The data illustrate that the genetic variability offered by PDXs means that such mouse models can be used, e.g., to determine the genes necessary for an unknown pathogen's transmissibility or infectability-not simply to support the replication of human viruses, which would not require PDX cancer cells. The utility of PDX cancer cells in assessing the role of host genetics in susceptibility to viral infection is not appreciated or contemplated in the prior art, and the skilled artisan, looking at Keck, Wahl, and Wu, would not arrive at the claimed method at least for the reasons presented above. Applicants’ arguments have been fully considered but are not found persuasive.
In response, the claimed method comprises two active step of (i) administering to a humanized immunodeficient mouse cancer cells of a human patient-derived xenograft (PDX) and (ii) and administering to the immunodeficient mouse a virus comprising a surface moiety that binds to the viral entry moiety. The claim as recited is broad and does not require any specific outcome or determination to distinguish from one disclosed in combination of prior art of record. In fact claim 1 does not even require engraftment of cancer cells of a PDX in the humanized immunodeficient mouse. In response to applicants’ argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., determine which receptor is used for infection of human, determine genetic profile heterogeneity/complexity or the role of host genetics in susceptibility to viral infection) 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). In the instant case, as stated above, applicants in part agree that Keck teaches administering to humanized immunodeficient mouse cancer cells of a human patient-derived xenograft (PDX). Keck further contemplate using the humanized mouse models that would permit human-specific infections and therapies, thus enabling clinically relevant in vivo studies of human cells, tissues, and immune systems (see para. 6, 158). As previously indicated, Wahl cure the deficiency by disclosing administering a humanized mouse with ectopically transplanted human lung tissue and human immune cells via bone marrow transplantation to study the infection of respiratory viruses (see fig. 1).. A variety of viruses suitable for this purpose are well-known in the art, including Zika or MERS-CoV virus (see above). To the extent that Wahl et al. describe infecting human lung cells in a humanized immunodeficient mouse, the rejection is applicable to the instant case. Applicants' selective reading of Keck. ignores the teachings of the reference of Wahl. There is no requirement for Keck.to teach that which is clearly taught by Wahl. Further, method of infecting lung cells of humanized mouse cancer cells as disclosed in Keck as argued by applicant is different from the method as claimed. "[T]he fact that [applicant] has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In the instant case, prior art explicitly reported using virus infection to study the humanized mouse model of cancer cells (see Keck). Applicants’ argument that claimed method of mouse models can be used to determine receptor that are used for infection of humans or determining or assaying varying expression levels of ACE2, CD147, and TMPRSS2 different cancerous human PDX samples and determine genes required for infectability is not required by the claim and therefore applicant’s argument is not commensurate with the scope.
On page 9 of the applicant’s argument, Applicant re-iterates prior arguments that are substantially the same as discussed in preceding section. The arguments are substantially the same as those addressed in foregoing sections.
Therefore, in view of the fact patterns of the instant case, and the ground of rejection outlined by the examiner, applicants' arguments are not compelling and do not overcome the rejection of record.
. Maintained-Claim Rejections - 35 USC § 112-written description -in modified form
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 33-39, 51-57 and 58 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claim embraces use of a humanized immunodeficient mouse cancer cells of a human patient-derived xenograft (PDX), , wherein the cancer cells comprise any viral entry moiety; and use of any virus comprising a surface moiety that binds to the viral entry moiety. Thus, claims encompass a genus of cancer cells of a PDX of any etiology and pathology, wherein the cancer cells comprise any know or yet to identified viral entry moiety and use of genus of viral comprising any surface moiety that binds to the viral entry moiety of known or yet to be identified virus.
In analyzing whether the written description requirement is met for the genus claim, it is determined whether a representative number of species have been sufficiently described by other relevant identifying characteristics, specific features and functional attributes that would distinguish different members of the claimed genus. Vas-Cath Inc. v. Mahurkar , 19USPQ2d 1111 (Fed. Cir. 1991), clearly states that ''applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed.'' Vas-cath Inc. v. Mahurkar , 19USPQ2d at 1 117. The specification does not ''clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.'' Vas-cath Inc. v.Mahurkar , 19USPQ2d at 1116.
The administering to a genus of a humanized mouse, any cancer cells or any etiology or pathology of a human PDX, wherein the cells comprise any viral entry moiety comprising any surface moiety that binds to the pathogen entry moiety is embraced by the breadth of the claim. The specification contemplates host cell moiety is selected from membrane proteins, lipids, and carbohydrate moieties, optionally present either on glycoproteins or glycolipids, whereas the pathogen is selected from bacteria, viruses, prions, and fungi (see page 2 of the specification) subsequently limiting to the a virus that is selected from a group consisting of a respiratory virus such as influenza viruses, respiratory syncytial viruses, parainfluenza viruses, adenoviruses, and coronaviruses (see page 3 of the specificaton0.
The art teaches successful targeting across different pathogen type depends on receptor binding. For instance, Noyce et al (PLoS Pathog7(8):e1002240., 1-24) teaches d Nectin-4 (PVRL4) as the long-sought epithelial cell receptor for the measles virus (MV) (see abstract). Wiles (Exp Mol Pathol. 2008 Apr 8;85(1):11–19) teaches diversity of known and putative UPEC-associated virulence genes, coupled with high levels of genetic overlap seen among both pathogenic and nonpathogenic extraintestinal E. coli isolates. This makes it difficult to attribute UPEC virulence to any one set of factors. Rather, it is likely that UPEC and other ExPEC strains have evolved multiple and redundant mechanisms to overcome the many challenges encountered within the host environment. (page 9 last para). Wiles concludes that multiple adhesions compensate for receptor differences and binding is not sufficient for colonization. In view of foregoing, it is apparent that many bacterial receptors binding would not reliably predict colonization. In view of foregoing, it is apparent that while receptor is necessary for many pathogens, however, many pathogens such as bacterial infection is a multistep and may involve redundant processes. In the instant case, specification did not demonstrate a reduction to practice of a genus of cells comprising a pathogen entry moiety and plurality of different pathogen comprising a surface moiety that binds to the pathogen entry moiety, nor did Applicant adequately describe the distinguishing identifying characteristics as evidenced by other descriptions of the invention that are sufficiently detailed to show that Applicant was in possession of the claimed genus of cells comprise a pathogen entry moiety and use of plurality of different pathogen comprising a surface moiety that binds to the pathogen entry moiety as embraced by the breadth of the claims.
The specification exemplified SARS-CoV-2 and human ACE2 levels in PDX-humanized mice after intranasal (IN) or intravenous (IV) infection with SARS-CoV-2 compared to uninfected (Un) mice (See fig. 3). Figure 8 shows SARS-CoV-2 infections in NSG mice humanized with different PDXs. (example 2). Based upon the prior art as discussed above is expected to be variation among different species of cancer cell of distinct etiology and pathology comprising entry moiety and different species and subspecies of known or yet to be identified virus comprising a surface moiety that binds to the pathogen entry moiety. There is no evidence on the record of a relationship between the entry moiety and surface moiety of the ACE2 and SARC-CoV2 to any of the embraced surface moiety and virus that would provide any reliable information about the any other surface moiety and virus within the claimed genus.
As such, the Artisan of skill could not conclude that Applicant possessed any additional combination of surface moiety and pathogen that binds to the pathogen entry moiety, except for ACE2 and SARC-CoV2 that is specifically described in specification (see example 2 of the specification). Hence, only ACE2 and SARC-CoV2 could be demonstrated as possessed for lung cancer cells derived from human PDX. There is no evidence on the record that any combination of surface moiety that does not uniquely correspond to the genus of known or yet to be identified entry moiety or yet to be identified viral entry moiety within the claimed genus.
The claimed invention as a whole is not adequately described if the claims require essential or critical elements which are not adequately described in the specification and which is not conventional in the art before the effective filing date of the invention. Possession may be shown by actual reduction to practice, clear depiction of the invention in a detailed drawing or by describing the invention with sufficient relevant identifying characteristics such that a person skilled in the art would recognize that the inventor had possession of the claimed invention. Pfaff v. Wells Electronics. Inc., 48 USPQ2d 1641, 1646 (1998). As such, the Artisan of skill could not conclude that Applicant possessed any additional species of sequences, except for that of ACE2 and SARC-CoV2.
The skilled artisan cannot envision the detailed chemical structure of the surface moiety and virus entry moiety within the claimed genus showing contemplated biological activity other than those described and exemplified in the specification, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) and Amgen lnc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 (Fed. Cir. 1991). In conclusion, this limited information is not deemed sufficient to reasonably convey to one skilled in the art that Applicant is in possession of genus of surface moiety and viral entry moiety as broadly claimed at the time the application was filed. Thus, it is concluded that the written description requirement is not satisfied for the claimed genus.
Response to arguments
Applicants disagree with the rejection arguing the skilled artisan would understand Applicant to be in possession of a given virus and its cognate viral entry moiety for use in the method of the amended claims. The experiments shown in the Examples utilize eight viruses across several viral classes. Applicants assert that viruses tested in the Examples are known to affect multiple organ systems, resulting in systemic, neurological, hepatic, and respiratory symptoms, among others. Additionally, the specification provides ample support for viruses and their cognate entry moieties (see, e.g., at least pp. 19-22 of the published application). Thus, the skilled artisan would readily be able to apply the teachings of the application to viruses generally, even beyond the numerous exemplified viruses. Applicants’ arguments have been fully considered but are not found persuasive.
In response, Applicant in part acknowledges that claim encompasses a genus of cancer cells of a PDX of any etiology and pathology, wherein the cancer cells comprise any know or yet to identified viral entry moiety and use of genus of viral comprising any surface moiety that binds to the viral entry moiety of known or yet to be identified virus. Applicants assert that experiments shown in the Examples utilize eight viruses across several viral classes. However, it appears that in vivo guidance provided in the specification is limited to use of SARS-CoV-2 and human ACE2 levels in PDX-humanized mice comprising human immune cells after intranasal (IN) or intravenous (IV) infection as compared to uninfected (Un) mice (See fig. 3). Thus, the specification only supports humanized immunodeficient mouse comprising mature human immune cells. Example 3 shows infecting PSX samples with four different viruses in an in vitro infectivity assay. The claims as presented recite use of any known or yet to be identified viruses and their cognate entry moieties. It is emphasized that cellular receptors for all viruses are not fully characterized and therefore one of skill in the art would not be able to identify the viral entry moiety recognized by genus of viruses including one that are not human viruses. The guidance provided in the specifications (pages 19-22) does not provide predictable support for the variation among different species of cancer cell of distinct etiology and pathology comprising entry moiety and different species and subspecies of known or yet to be identified virus comprising a surface moiety that binds to the virus entry moiety, wherein viruses such as Vaccinia virus whose entry mechanisms are unknown or complex (see page 1076, col. 2, para. 2 in Grove JCB, 2011, 195 No. 7 1071–1082, cited as evidence without relying on rejection). Hence, only ACE2 and SARC-CoV2 could be demonstrated as possessed in humanized mouse comprising human immune cells and lung cancer cells derived from human PDX.
Therefore, in view of the fact patterns of the instant case, and the ground of rejection outlined by the examiner, applicants' arguments are not compelling and do not overcome the rejection of record.
Conclusion
No claims allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ashraf (Physiol Genomics 53: 51–60, Dec. 4, 2020) and Pujhari (Virulence, May 20, 2020. 11(1) 486–488) teaches mice comprising a humanized lung and immune system to study SARS-CoV-2 infections (see figure 1).
Applicants’ 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 ANOOP K. SINGH whose telephone number is (571)272-3306. The examiner can normally be reached Monday-Friday, 8AM-5PM. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at (571)272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANOOP K SINGH/ Primary Examiner, Art Unit 1632
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