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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 18, 20-24 and New Claims 37-43) and of the species (hapten: 2,4-dinitrofluorobenzene) in the reply filed on 05/26/2026 is acknowledged. Claims 18, 20-24 and 37-43 were examined on their merits.
Specification
The use of the term SEQUEST™, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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.
Claim 22 is 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. Regarding Claim 22, the phrase "including" which is also part of a parenthetical phrase, renders the claim indefinite because it is unclear whether the limitation(s) following the phrase in the parentheses are part of the claimed invention. See MPEP § 2173.05(d).
Regarding Claims 37-38, it is unclear whether the parenthetical limitations are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claims 18, 20-24 and 39-43 are rejected under 35 U.S.C. § 103 as being unpatentable over Pinteur et al. (US 2016/0296610 A1), cited in the IDS, in view of Zhou et al. (2016), of record.
Pinteur et al. teaches a composition comprising; tumor cell stress proteins
induced by in vitro stress and cells selected from cell line cells (Pg. 12, Claims 8 and
10);
wherein the composition is administered to a cancerous patient as an anti-cancer
treatment (Pg. 12, Claim 14);
and wherein the cell lines are from lines of the same type of tumor of the patient
to be treated (Pg. 6, Paragraph [0073]), reading on Claim 18.
Pinteur et al. further teaches the use of the mouse colon carcinoma line CT26-WT (ATCC CRL-2638) (Pg. 10, Paragraph [0152]).
With regard to Claim 20, Pinteur et al. teaches the method includes a step of inactivation of tumor cells to render them non-proliferative (Pgs. 2-3, Paragraph [0026]).
With regard to Claims 21 and 22, Pinteur et al. teaches the cells and/or stress proteins are haptenized, wherein the hapten is 2,4-dinitrofluorobenzene (Pg. 5, Paragraphs [0060]-[0061] and Pg. 6, Paragraph [0070]).
With regard to Claim 23, Pinteur et al. teaches the cells and/or stress proteins may be mixed with a pharmaceutically acceptable excipient (Pg. 6, Paragraph [0070]).
With regard to Claim 24, Pinteur et al. teaches the administered dose may be from 105 to 107 tumor cells (overlapping the claimed range of from about 105 to 108 tumor cells) (Pg. 8, Paragraph [0115]).
With regard to Claim 39, Pinteur et al. teaches the stressed tumor cells express HSP70 (Pgs. 6-7, Paragraph [0082] and Pg. 7, Paragraph [0084]).
With regard to Claims 40-44, Pinteur et al. teaches the stress may be:
radiation between around 0.25 and around 25 Gy for between around 1-20 minutes (Pg. 4, Paragraph [0047]);
a thermal shock at a temperature between around 38-45 °C for between around 20-100 minutes (Pg. 4, Paragraph [0048]);
a chemical shock, such as ethanol for around 1-48 hours (Pg. 4, Paragraph [0049]);
a metabolic stress, such as at least two of; hypoxia, deficiency or low pH (Pg. 4, Paragraph [0050]), or a combination of at least two of these stresses (Pg. 4, Paragraph [0051]).
Pinteur et al. does not teach wherein the composition comprises HT-29, HCT-
116 and LoVo cells, as required by Claim 18.
Zhou et al. (2016) teaches that HT-29, HCT-116 and LoVo cells are all known
colorectal cancer cell lines (Pg. 7658, Column 1, "Results", Lines 1-9).
It would have been obvious to those of ordinary skill in the art before the effective
filing date of the claimed invention to modify the method of Pinteur et al. of a
composition of generic tumor cell line cells and stress proteins therefrom to use the HT-
29, HCT-116 and LoVo colorectal cancer cell lines taught by Zhou et al. in place of the
generic tumor cell lines because Pinteur teaches non-specific tumor cell lines and Zhou
provides specific tumor cell lines suitable for use in the method. Those of ordinary skill
in the art would have been motivated to make this modification in order to obtain a
composition suitable as an anti-cancer treatment for colorectal cancer. There would
have been a reasonable expectation of success in making this modification because
Pinteur is drawn to a composition comprising generic tumor cell lines and Zhou teaches
particular tumor cell lines.
Claims 18, 20-24, 37 and 38-43 are rejected under 35 U.S.C. § 103 as being unpatentable over Pinteur et al. (US 2016/0296610 A1), cited in the IDS, in view of Zhou et al. (2016), of record, as applied to Claims 18, 20-24 and 39-43 above, and further in view of Teoh et al. (WO 2017/074257 A1).
The teachings of Pinteur et al. and Zhou et al. were discussed above.
Neither reference taught wherein the tumor cells were HCT-116 human colorectal cancer cells, as required by Claim 37.
Teoh et al. teaches bacterial anti-cancer agents (Abstract) which are tested on cancer cells cultures of CT26 murine colorectal cancer cells (as taught by Pinteur above) and HCT116 human colorectal cancer cells (Pg. 20, Paragraph [0065]).
It would have been obvious to those of ordinary skill in the art before the effective
filing date of the claimed invention to modify the method of Pinteur et al. of a
composition of CT26 tumor cells and stress proteins therefrom to use the HCT-116 colorectal cancer cell lines taught by Teoh et al. because both cell lines are art-recognized equivalent colorectal cancer cell lines for biological applications. See the MPEP at 2144.06, II. Those of ordinary skill in the art would have been motivated to make this modification based on cell line availability and/or artisan preference.
There would have been a reasonable expectation of success in making this modification because Pinteur is drawn to a composition derived from a mouse colorectal tumor cell line and Zhou teaches an equivalent human colorectal tumor cell line.
Claims 18, 20-24 and 38-43 are rejected under 35 U.S.C. § 103 as being unpatentable over Pinteur et al. (US 2019/0038731 A1), cited in the IDS, in view of Zhou et al. (2016), of record.
Pinteur et al. (‘731) teaches a pharmaceutical composition comprising immunogenic tumor cell stress proteins and/or non-proliferating tumor cells comprising immunogenic stress proteins, wherein the stress proteins have been induced on tumoral cells through in vitro stress selected from the group consisting of irradiation, heat, chemical and metabolic stress, and a pharmaceutically acceptable excipient (Pg. 12, Claim 8), and reading on Claims 18, 20 and 23.
Pinteur et al. (‘731) further teaches the use of the mouse colon carcinoma line CT26-WT (ATCC CRL-2638) (Pg. 10, Paragraph [0155]).
With regard to Claim 21, Pinteur et al. (‘731) teaches the composition comprises non-proliferating tumor cells or fragments of such cells, bearing or containing haptenised stress proteins (Pg. 12, Claim 9).
With regard to Claim 22, Pinteur et al. (‘731) teaches the hapten is 2,4-dinitrofluorobenzene (Pg. 10, Paragraphs [0158]).
With regard to Claim 24, Pinteur et al. (‘731) teaches the administered dose may be from 105 to 107 tumor cells (overlapping the claimed range of from about 105 to 108 tumor cells) (Pg. 8, Paragraph [0118]).
With regard to Claims 38 and 39, Pinteur et al. (‘731) teaches the stressed tumor cells express HSP70 (Pg. 7, Paragraphs [0084]-[0086]).
With regard to Claims 40-44, Pinteur et al. (‘731) teaches the stress may be:
radiation between around 0.25 and around 25 Gy for between around 1-20 minutes (Pg. 4, Paragraph [0048]);
a thermal shock at a temperature between around 38-45 °C for between around 20-100 minutes (Pg. 4, Paragraph [0049]);
a chemical shock, such as ethanol for around 1-48 hours (Pg. 4, Paragraph [0050]);
a metabolic stress, such as at least two of; hypoxia, deficiency or low pH (Pg. 4, Paragraph [0051]), or a combination of at least two of these stresses (Pg. 4, Paragraph [0052]).
Zhou et al. (2016) teaches that HT-29, HCT-116 and LoVo cells are all known
colorectal cancer cell lines (Pg. 7658, Column 1, "Results", Lines 1-9).
It would have been obvious to those of ordinary skill in the art before the effective
filing date of the claimed invention to modify the method of Pinteur et al. (‘731) of a
composition of generic tumor cell line cells and stress proteins therefrom to use the HT-
29, HCT-116 and LoVo colorectal cancer cell lines taught by Zhou et al. in place of the
generic tumor cell lines because Pinteur teaches non-specific tumor cell lines and Zhou
provides specific tumor cell lines suitable for use in the method. Those of ordinary skill
in the art would have been motivated to make this modification in order to obtain a
composition suitable as an anti-cancer treatment for colorectal cancer. There would
have been a reasonable expectation of success in making this modification because
Pinteur is drawn to a composition comprising generic tumor cell lines and Zhou teaches
particular tumor cell lines.
Claims 18, 20-24, 37 and 38-43 are rejected under 35 U.S.C. § 103 as being unpatentable over Pinteur et al. (US 2019/0038731 A1), cited in the IDS, in view of Zhou et al. (2016), of record, as applied to Claims 18, 20-24 and 39-43 above, and further in view of Teoh et al. (WO 2017/074257 A1).
The teachings of Pinteur et al. (‘731) and Zhou et al. were discussed above.
Neither reference taught wherein the tumor cells were HCT-116 human colorectal cancer cells, as required by Claim 37.
Teoh et al. teaches bacterial anti-cancer agents (Abstract) which are tested on cancer cells cultures of CT26 murine colorectal cancer cells (as taught by Pinteur [‘731] above) and HCT116 human colorectal cancer cells (Pg. 20, Paragraph [0065]).
It would have been obvious to those of ordinary skill in the art before the effective
filing date of the claimed invention to modify the method of Pinteur et al. (‘731) of a
composition of CT26 tumor cells and stress proteins therefrom to use the HCT-116 colorectal cancer cell lines taught by Teoh et al. because both cell lines are art-recognized equivalent colorectal cancer cell lines for biological applications. See the MPEP at 2144.06, II. Those of ordinary skill in the art would have been motivated to make this modification based on cell line availability and/or artisan preference. There would have been a reasonable expectation of success in making this modification because Pinteur is drawn to a composition derived from a mouse colorectal tumor cell line and Zhou teaches an equivalent human colorectal tumor cell line.
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 18, 20, 21, 22, 23, 24, 39, 40, 41, 42 and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 12 of U.S. Patent No. 11,096,995 B2 in view of Pinteur et al. (US 2016/0296610 A1), cited in the IDS, in view of Zhou et al. (2016), of record.
The instant claims are drawn to a composition comprising (i) stressed tumor cells derived from human colorectal cell lines HT-29, HCT-116 and LoVo cells, and (ii) immunogenic stress proteins produced by these cells in response to a stress applied in vitro, wherein the stress is selected from radiation, thermal stress, chemical stress, metabolic stress, and any combination thereof.
This is made obvious by the ‘995 Patent which teaches a pharmaceutical composition or vaccine comprising tumor cells, a plurality of different immunogenic stress proteins, and a pharmaceutically acceptable excipient, wherein said tumor cells developed a viable resistance mechanism in response to a stress applied in vitro thereto, said plurality of different immunogenic stress proteins also produced by said stress applied in vitro to said tumor cells, and wherein said stress applied in vitro to said tumor cells is selected from the group consisting of irradiation, heat shock, chemical shock, metabolic stress, and combinations thereof, reading on instant Claims 18, 40 and 42.
Instant Claims 20 and 21 are made obvious by Claims 12 and 2, respectively of the ‘995 Patent.
The ‘995 Patent does not teach wherein the composition comprises HT-29, HCT-
116 and LoVo cells, as required by Claim 18.
wherein the hapten is 2,4-dinitrobenzene, as required by instant Claim 22;
wherein the composition comprises an excipient, as required by instant Claim 23;
wherein the composition comprises from about 105 to about 108 stressed tumor cells, as required by Claim 24;
wherein the stressed tumor cells express HSP70, as required by Claim 39;
wherein: (i) the metabolic stress is an in vitro culture in a depleted medium, under hypoxia, and/or at low pH; (ii) the radiation is an in vitro radiation with a total dose ranging from about 0.25 to about 25 Gy, for a period ranging from about 1 to about 20 minutes; and (iii) the thermal stress is an in vitro thermal shock at a temperature ranging from about 38°C to about 45°C, for a period ranging from about 15 minutes to about 4 hours, as required by Claim 41;
or wherein (i) the metabolic stress is an in vitro culture in a depleted medium, under hypoxia, and/or at low pH; and (ii) the chemical stress is an in vitro exposure to at least one chemotherapeutic agent and/or alcohol, for a period ranging from about 6 hours to about 120 hours, as required by Claim 43.
Zhou et al. (2016) teaches that HT-29, HCT-116 and LoVo cells are all known
colorectal cancer cell lines (Pg. 7658, Column 1, "Results", Lines 1-9).
Pinteur et al. teaches a composition comprising tumor cell stress proteins
induced by in vitro stress and cells selected from cell line cells (Pg. 12, Claims 8 and
10);
wherein the composition is administered to a cancerous patient as an anti-cancer
treatment (Pg. 12, Claim 14);
and wherein the cell lines are from lines of the same type of tumor of the patient
to be treated (Pg. 6, Paragraph [0073]).
With regard to Claim 22, Pinteur et al. teaches the cells and/or stress proteins are haptenized, wherein the hapten is 2,4-dinitrofluorobenzene (Pg. 5, Paragraphs [0060]-[0061] and Pg. 6, Paragraph [0070]).
With regard to Claim 23, Pinteur et al. teaches the cells and/or stress proteins may be mixed with a pharmaceutically acceptable excipient (Pg. 6, Paragraph [0070]).
With regard to Claim 24, Pinteur et al. teaches the administered dose may be from 105 to 107 tumor cells (overlapping the claimed range of from about 105 to 108 tumor cells) (Pg. 8, Paragraph [0115]).
With regard to Claim 39, Pinteur et al. teaches the stressed tumor cells express HSP70 (Pgs. 6-7, Paragraph [0082] and Pg. 7, Paragraph [0084]).
With regard to Claims 40-44, Pinteur et al. teaches the stress may be:
radiation between around 0.25 and around 25 Gy for between around 1-20 minutes (Pg. 4, Paragraph [0047]);
a thermal shock at a temperature between around 38-45 °C for between around 20-100 minutes (Pg. 4, Paragraph [0048]);
a chemical shock, such as ethanol for around 1-48 hours (Pg. 4, Paragraph [0049]);
a metabolic stress, such as at least two of; hypoxia, deficiency or low pH (Pg. 4, Paragraph [0050]), or a combination of at least two of these stresses (Pg. 4, Paragraph [0051]).
It would have been obvious to those of ordinary skill in the art before the effective
filing date of the claimed invention to modify the method of the ‘995 Patent of a pharmaceutical composition or vaccine comprising stressed tumor cells and a plurality of different immunogenic stress proteins with the method of Pinteur et al. of a composition comprising tumor cell stress proteins induced by in vitro stress and cells selected from cell line cells because this is no more than the combining of two stress cells/protein compositions for the same purpose (anti-cancer treatments). See the MPEP at 2144/06, I.
It would have been further obvious to modify the method of the ‘995 Patent of a composition of generic tumor cell line cells and stress proteins therefrom to use the HT-29, HCT-116 and LoVo colorectal cancer cell lines taught by Zhou et al. in place of the generic tumor cell lines because the patent teaches non-specific tumor cell lines and Zhou provides specific tumor cell lines suitable for use in the method. Those of ordinary skill in the art would have been motivated to make this modification in order to obtain a composition suitable as an anti-cancer treatment for colorectal cancer.
There would have been a reasonable expectation of success in making this modification because both the ‘995 patent and Pinteur are drawn to a composition comprising generic tumor cell lines and Zhou teaches particular tumor cell lines.
Claims 18, 20-24, 37 and 38-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 12 of U.S. Patent No. 11,096,995 B2 in view of Pinteur et al. (US 2016/0296610 A1), cited in the IDS, in view of Zhou et al. (2016), of record, as applied to Claims and further in view of Teoh et al. (WO 2017/074257 A1).
The teachings of the ‘995 patent, Pinteur et al. (‘731) and Zhou et al. were discussed above.
None of the above references taught wherein the tumor cells were HCT-116 human colorectal cancer cells, as required by Claim 37.
Teoh et al. teaches bacterial anti-cancer agents (Abstract) which are tested on cancer cells cultures of CT26 murine colorectal cancer cells (as taught by Pinteur above) and HCT116 human colorectal cancer cells (Pg. 20, Paragraph [0065]).
It would have been obvious to those of ordinary skill in the art before the effective
filing date of the claimed invention to modify the method of the ‘995 Patent and Pinteur et al. of a composition of CT26 tumor cells and stress proteins therefrom to use the HCT-116 colorectal cancer cell lines taught by Teoh et al. because both cell lines are art-recognized equivalent colorectal cancer cell lines for biological applications. See the MPEP at 2144.06, II. Those of ordinary skill in the art would have been motivated to make this modification based on cell line availability and/or artisan preference. There would have been a reasonable expectation of success in making this modification because at least the ‘995 Patent and Pinteur are drawn to compositions derived from a mouse colorectal tumor cell line and Zhou teaches an equivalent human colorectal tumor cell line.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Sharmila G 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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/PAUL C MARTIN/Examiner, Art Unit 1653 06/09/2026
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