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 .
Response to Amendment
The amendment filed 04/23/2026, amending claim(s) 75, 77, and 98 is acknowledged. Applicant’s amendments to the claims have overcome the 112(b) rejection previously set forth in the Non-Final Office Action mailed 10/27/2025.
Claims 75-77 and 80-98 are pending and under examination.
Information Disclosure Statement
The information disclosure statement filed 04/23/2026 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application provisional applications 63/261,099 filed on 9/10/2021, 63/197,315 filed 6/4/2021, 63/200,329 filed 3/1/2021, and PCT applications PCT/US21/048532 filed 8/31/2021, PCT/US2021/020922 filed 3/4/2021 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications listed above fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
United States Court of Appeals for the Federal Circuit, Regents of the University of Minnesota v. Gilead Sciences, Inc (Case 21-2168; decided March 6, 2023).
Written description of a broad genus requires description not only of the outer limits of the genus but also of either a representative number of members of the genus or structural features common to the members of the genus, in either case with enough precision that a relevant artisan can visualize or recognize the members of the genus. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350−52 (Fed. Cir. 2010) (en banc). A broad outline of a genus’s perimeter is insufficient. See id.
Original disclosure may not be relied upon unless it “constitute[s] a full, clear, concise and exact description” of the invention claimed in the pa-tent to one of ordinary skill. In re Wertheim, 646 F.2d 527, 538–39 (CCPA 1981).
For genus claims, which are present here, we have looked for blaze marks within the disclosure that guide attention to the claimed species or subgenus. In re Ruschig, 379 F.2d 990, 994–95 (CCPA 1967); Fujikawa v. Wattana-sin, 93 F.3d 1559, 1571 (Fed. Cir. 1996); see also Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326–27 (Fed. Cir. 2000).
Following this maze-like path, each step providing multiple alternative paths, is not a written description of what might have been described if each of the optional steps had been set forth as the only option. This argument calls to mind what Yogi Berra, the Yankee catcher, was reported to have said: “when one comes to a fork in the road, take it.” That comment was notable because of its indeterminacy, its lack of direction. Similarly, here, all those optional choices do not define the intended result of the instant combination of specific method step parameters.
Clearly, however, just because a moiety is listed as one possible choice for one position does not mean there is ipsis verbis support for every species or sub-genus that chooses that moiety. Were this the case, a “laundry list” disclosure of every possible moiety for every possible position would constitute a written description of every species in the genus. This cannot be because such a disclosure would not “reasonably lead” those skilled in the art to any particular species.
Indeed, the listings of possibilities are so long, and so interwoven, that it is quite unclear how many compounds actually fall within the described genera and subgenera.
As explained by the Board, “[t]hese blaze marks must be clear because ‘it is easy to bypass a tree in the forest, even one that lies close to the trail.’” Decision at *10 (citing Fujikawa, 93 F.3d at 1571).
The Board concluded that, “[i]n this case, we find the point at which one must leave the trail to find the tree is not well marked in [provisional application]. Thus, [provisional application] do not provide sufficient written description support for the sub-genus of challenged claim 1.” Decision at *10.
With respect to Claim 75, of which claims 76, 77, and 80-98 are dependent upon, the limitation of the formulation comprising 0.5 to 10% dextran, wherein the molecular weight of the dextran is greater than 10 kDa is not supported in any of the applications applicant has claimed priority to. The examiner notes that the Non-Final Office Action filed 11/17/2023 previously stated that the limitation of the formulation comprising a colloid as recited in claim 75 is not supported in any of the applications applicant has claimed priority to.
Further, while the instant specification discloses that the formulation can include one or more of dextran(40 kDa to 2,000 kDa, or 40 kDa to 2 x 10^6 kDa) [0182], the formulation may include 0.5% to 2% Dextran40 or comprise 0.75% to 1.5% Dextran40 [0924], 0.5 to 10% colloid [0951], 0.5 to 20% dextran40 [0953], 5 to 12% dextran40 [0953], the limitation of the formulation comprising 0.5 to 10% dextran, wherein the molecular weight of the dextran is greater than 10 kDa is not supported by the instant disclosure as originally filed or working examples.
There are no blazemarks to select a concentration of anywhere from 0.5 to 10% of dextran, wherein the molecular weight of the dextran is greater than 10 kDa.
United States Court of Appeals for the Federal Circuit, FWP IP APS v. Biogen MA, Inc (Case 2017-2109; decided October 24, 2018).
Piecing together elements of several claims and/or disparate portions of the specification to arrive at the specifically claimed subject matter does not satisfy the written description requirement. The task of locating the now-claimed subject matter within the original claims is made uncommonly more difficult by the original claims themselves, which are written in a cascading, multiple dependencies manner such that many of them generically refer back to any one of the preceding claims. Title 35 forbids this type of claim drafting because it can—as here—lead to bizarrely complex chains of cross-referencing claims in which one multiple dependent claim impermissibly serves as a basis for other multiple dependent claims. Finding the presently recited combination of specific experimental parameters, including the specific combination of disparate subgenus experimental parameters “in the morass of possible combinations of the impermissibly-drafted original claims would-- as Judge Learned Hand
observed in a different but related context—take “the patience of a yogi to decipher their meaning, as they stand.” Victor Talking Mach. Co. v. Thomas A. Edison, Inc., 229 F. 999, 1001 (2d Cir. 1916). A review of the claims and their intermixing dependencies presents an overall picture of a set of claims designed to preempt a conspicuously large number of different dosage regimens for a large variety of conditions using a long list of formulations, which is disconnected from a written description that is far more limited in its disclosure.
The disclosures of 63/261,099, 63/197,315, 63/200,329, PCT/US21/048532, and PCT/US2021/020922 fail to provide ipsis verbis support nor sufficient blaze marks to guide the skilled artisan to the claims of the instant application.
Accordingly, the effective priority date of Claims 52, 58, 61, and 71-72 is granted as the filing date of the instant application, March 1st, 2022.
If applicant believes the earlier applications provide support for this disclosure, applicant should point out such support with particularity by page and line number in the reply to this Action.
Claim Rejections - 35 USC § 112(a) – Written Description; Maintained
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 75-77 and 80-98 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.
Claim 75 recites a formulation, wherein the formulation comprises:
a) greater than 10 million transducing units (TUs)/ml, wherein the TUs are replication incompetent retroviral particles (RIPs), wherein the RIPs comprise:
i) an activation element on the surface of the RIPs, wherein the activation element comprises a polypeptide capable of binding to a TCR complex polypeptide; and
ii) a polynucleotide comprising one or more transcriptional units, wherein each of the one or more transcriptional units is operatively linked to a promoter active in T cells, and wherein the one or more transcriptional units encode a first polypeptide and/or an inhibitory RNA molecule; and
b) 0.5% to 10% dextran, wherein the molecular weight of the dextran is greater than 10 kDa.
United States Court of Appeals for the Federal Circuit, Regents of the University of Minnesota v. Gilead Sciences, Inc (Case 21-2168; decided March 6, 2023).
Written description of a broad genus requires description not only of the outer limits of the genus but also of either a representative number of members of the genus or structural features common to the members of the genus, in either case with enough precision that a relevant artisan can visualize or recognize the members of the genus. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350−52 (Fed. Cir. 2010) (en banc). A broad outline of a genus’s perimeter is insufficient. See id.
Original disclosure may not be relied upon unless it “constitute[s] a full, clear, concise and exact description” of the invention claimed in the pa-tent to one of ordinary skill. In re Wertheim, 646 F.2d 527, 538–39 (CCPA 1981).
For genus claims, which are present here, we have looked for blaze marks within the disclosure that guide attention to the claimed species or subgenus. In re Ruschig, 379 F.2d 990, 994–95 (CCPA 1967); Fujikawa v. Wattana-sin, 93 F.3d 1559, 1571 (Fed. Cir. 1996); see also Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326–27 (Fed. Cir. 2000).
Following this maze-like path, each step providing multiple alternative paths, is not a written description of what might have been described if each of the optional steps had been set forth as the only option. This argument calls to mind what Yogi Berra, the Yankee catcher, was reported to have said: “when one comes to a fork in the road, take it.” That comment was notable because of its indeterminacy, its lack of direction. Similarly, here, all those optional choices do not define the intended result of the instant combination of specific method step parameters.
Clearly, however, just because a moiety is listed as one possible choice for one position does not mean there is ipsis verbis support for every species or sub-genus that chooses that moiety. Were this the case, a “laundry list” disclosure of every possible moiety for every possible position would constitute a written description of every species in the genus. This cannot be because such a disclosure would not “reasonably lead” those skilled in the art to any particular species.
Indeed, the listings of possibilities are so long, and so interwoven, that it is quite unclear how many compounds actually fall within the described genera and subgenera.
As explained by the Board, “[t]hese blaze marks must be clear because ‘it is easy to bypass a tree in the forest, even one that lies close to the trail.’” Decision at *10 (citing Fujikawa, 93 F.3d at 1571).
The Board concluded that, “[i]n this case, we find the point at which one must leave the trail to find the tree is not well marked in [62/020,163]. Thus, [62/020,163] do not provide sufficient written description support for the sub-genus of challenged claim 1.” Decision at *10.
With respect to Claim 75, of which claims 76, 77, and 80-98 are dependent upon, the limitation of the formulation comprising 0.5 to 10% dextran, wherein the molecular weight of the dextran is greater than 10 kDa is not supported in any of the applications applicant has claimed priority to. The examiner notes that the Non-Final Office Action filed 11/17/2023 previously stated that the limitation of the formulation comprising a colloid as recited in claim 75 is not supported in any of the applications applicant has claimed priority to.
Further, while the instant specification discloses that the formulation can include one or more of dextran(40 kDa to 2,000 kDa, or 40 kDa to 2 x 10^6 kDa) [0182], the formulation may include 0.5% to 2% Dextran40 or comprise 0.75% to 1.5% Dextran40 [0924], 0.5 to 10% colloid [0951], 0.5 to 20% dextran40 [0953], 5 to 12% dextran40 [0953], the limitation of the formulation comprising 0.5 to 10% dextran, wherein the molecular weight of the dextran is greater than 10 kDa is not supported by the instant disclosure as originally filed or working examples of the instant specification.
There are no blazemarks to select a concentration of anywhere from 0.5 to 10% of dextran, wherein the molecular weight of the dextran is greater than 10 kDa.
United States Court of Appeals for the Federal Circuit, FWP IP APS v. Biogen MA, Inc (Case 2017-2109; decided October 24, 2018).
Piecing together elements of several claims and/or disparate portions of the specification to arrive at the specifically claimed subject matter does not satisfy the written description requirement. The task of locating the now-claimed subject matter within the original claims is made uncommonly more difficult by the original claims themselves, which are written in a cascading, multiple dependencies manner such that many of them generically refer back to any one of the preceding claims. Title 35 forbids this type of claim drafting because it can—as here—lead to bizarrely complex chains of cross-referencing claims in which one multiple dependent claim impermissibly serves as a basis for other multiple dependent claims. Finding the presently recited combination of specific experimental parameters, including the specific combination of disparate subgenus experimental parameters “in the morass of possible combinations of the impermissibly-drafted original claims would-- as Judge Learned Hand
observed in a different but related context—take “the patience of a yogi to decipher their meaning, as they stand.” Victor Talking Mach. Co. v. Thomas A. Edison, Inc., 229 F. 999, 1001 (2d Cir. 1916). A review of the claims and their intermixing dependencies presents an overall picture of a set of claims designed to preempt a conspicuously large number of different dosage regimens for a large variety of conditions using a long list of formulations, which is disconnected from a written description that is far more limited in its disclosure.
The disclosures of 63/261,099, 63/197,315, 63/200,329, PCT/US21/048532, and PCT/US2021/020922 fail to provide ipsis verbis support nor sufficient blaze marks to guide the skilled artisan to the claims of the instant application.
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. The disclosure of a single species is rarely, if ever, sufficient to describe a broad genus, particularly when the specification fails to describe the features of that genus, even in passing. (see In re Shokal 113USPQ283(CCPA1957); Purdue Pharma L.P. vs Faulding Inc. 56 USPQ2nd 1481 (CAFC 2000).
The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.). See also In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997).
The specification fails to disclose a nexus between the required parameters of the formulation of independent claim 75:
replication incompetent retroviral particles (RIPs) (i.e., transducing units) (greater than 10 million transducing units (TUs)/ml); and
the concentration and weight of dextran (range 0.5% to 10%; greater than 10 kDa);
whereupon said formulation is further limited to:
comprises greater than 50 million TUs/ml (claim 76);
molecular weight of the colloid is greater than 40 kDa (claim 77); and/or
the formulation comprises 1% to 5% dextran (claim 97);
individually and/or in combination and/or subcombinations thereof.
There is no reduction to practice in the specification of formulating:
the recited range of RIPs in combination with,
the recited range of % dextran in,
the recited range of dextran size.
The working examples (which start at [1002]) recited in the specification do not disclose the use of dextran at all in a formulation. The only colloid used in the working examples is PEG [1006].
Additionally, as evidenced below, the art teaches that a much lower concentration of dextran is typically used for the transduction of retroviral particles. The specification fails to disclose the criticality of the recited range of 0.5% to 10% of dextran for retroviral transduction.
Kahn, Mark L., Sung W. Lee, and David A. Dichek. "Optimization of retroviral vector-mediated gene transfer into endothelial cells in vitro." Circulation research 71.6 (1992): 1508-1517. is considered relevant prior art for teaching concentrations from 4 to 80 micrograms/ml (about .0004% to .008%) of DEAE-dextran used for successful retroviral transduction (the retrovirus comprising Moloney murine leukemia virus (pg. 1509, col 1, “Retroviral Vectors and Vector Supernatant”; pg. 1511, col 1, “Determination of the contributions of the polycations Polybrene and DEAE-dextran to TE”; Table 2).
Jaffee, Elizabeth M., et al. "High efficiency gene transfer into primary human tumor explants without cell selection." Cancer research 53.10 (1993): 2221-2226 is considered relevant prior art for teaching the transduction of primary human tumor cultures with a vector comprising Moloney murine leukemia virus (i.e., a replication incompetent retrovirus) with 70 micrograms/ml of DEAE-dextran (Sigma, St. Louis. MO; D-9885) (D-9885 is dextran 500, see attached Sigma NPL).
Landázuri, Natalia, et al. "Retrovirus‐polymer complexes: study of the factors affecting the dose response of transduction." Biotechnology progress 23.2 (2007): 480-487 is considered relevant prior art for teaching retroviral (alpha-SGC-LacZ) transduction of NIH 3T3 mouse fibroblasts using dextran sulfate (DS) (molecular weight 500 kDa) at a concentration ranging from 120 to 240 micrograms/ml (about .012% to .024%) (Tables 1 and 2; pg. 481, col 1, “Cell culture”).
Thus, for the reasons outlined above, it is concluded that the claims do not meet the requirements for written description under 35 U.S.C. 112, first paragraph.
MPEP 2163 - 35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the “specification shall contain a written description of the invention ....” This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc)
If applicant believes the earlier applications provide support for this disclosure, applicant should point out such support with particularity by page and line number in the reply to this Action.
Applicant does not indicate where these limitations are supported by the original specification, or how, as is Applicant's burden. See MPEP §714.02, last sentence of the third paragraph from the end and MPEP §2163.06 (I) last sentence.
Response to Arguments
Applicant's arguments filed 04/23/2026 have been fully considered but they are not persuasive.
Regarding the 112(a) rejection, the Applicant argues [0958] of the instant specification provides sufficient support for the limitation “0.5% to 10% dextran”. This argument is not persuasive because the range 0.5% to 10% is generic to the genus of colloids. % dextran is taught in [0924] and [0955-0953], and dextran is not recited in [0958]. As such, there is no clear guidance for an artisan to follow to select 0.5% to 10% dextran out of the entire instant specification. Further, the Applicant fails to address the art teaching typically using a much lower concentration of dextran for the transduction of retroviral particles (e.g., an Artisan cannot refer to the prior art for direction/guidance to use 0.5% to 10% dextran), and does not distinctly point out the criticality of the recited range of 0.5% to 10% of dextran for retroviral transduction.
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 ALLISON M JOHNSON whose telephone number is (703)756-1396. The examiner can normally be reached Monday-Friday 9am-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, Tracy Vivlemore can be reached on (571) 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALLISON MARIE JOHNSON/Examiner, Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638
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