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 .
DETAILED ACTION
Claims 1-12 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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Claim Objections
Claim 1 is objected to because of the following informalities: in claim 1, line 10, “lung” is incorrectly spelled as “lunch.”
Appropriate correction is required.
Claim Interpretation
In claim 1, lines 3-6 and 11, the limitations “is prepared by injecting a first liquid composition comprising docetaxel and ethanol into an infusion bag or bottle containing a second aqueous composition comprising serum albumin in a parenterally acceptable vehicle” and “is prepared within 24 hours,” respectively, are product-by-process limitations.
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), see MPEP 2113.
Product-by-Process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially identical is found and a prior art rejection is made, the burden shifts to the applicant to show a nonobvious difference. See above paragraph and MPEP 2113.
In claim 1, the limitations a) “for infusion” in line 1, b) “is administered by infusion to treating a patient diagnosed with a solid tumor. . .and neck cancer,” in lines 8-10, c) “wherein the dose of docetaxel is infused to said patient in need thereof is about 75 mg/m2,” in lines 11-12, d) “prior to being infused to said patient,” in the last 2 lines, and the limitation “infusion” in claim 5, and the limitations of instant claims 2 and 6-12, are intended use limitations.
If the prior art composition is capable of performing the intended use, then it meets the limitations of the claim. See MPEP 2112.01 and 2111.02. Therefore, the intended use of the composition is being considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim.
In view of the product-by-process and intended-use limitations, claim 1 is interpreted as a pharmaceutical composition comprising docetaxel, human serum albumin, ethanol, and a parenterally acceptable vehicle.
The limitations of claims 6-12 are interpreted as intended-use limitations.
In claims 1-12, the recitation “the composition” is interpreted as referring back to “A pharmaceutical composition” as referenced in line 1 of claim 1, and not as referring to “a first liquid composition” or “a second aqueous composition” as recited in lines 3-4 of claim 1.
Claim Rejections - 35 USC § 102 & 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-12 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over WO 2018/081520 to Sun (published 2018, IDS of 08/19/2025).
Regarding claim 1 and 5, Sun teaches a composition comprising docetaxel, and human serum albumin dissolved in an aqueous solvent, such as ethanol in water, wherein water is a parenterally acceptable vehicle, wherein the composition does not contain polysorbate 80, and wherein the composition is a clear aqueous solution (pg. 110, claims 3, 7, 11, 14-15, 16; pgs. 90-99, 105 Examples 1-18, 20, 23-24).
Regarding claim 3, Sun exemplifies formulations comprising 0.025, 0.05, 0.075, 0.1, 0.15, 0.2, and 0.25mg/ml concentrations of docetaxel (pg. 99, example 19).
Regarding claim 4, Sun exemplifies a composition comprising docetaxel and 20% concentration of human serum albumin (pg. 99, Example 18; pg. 105, claim 23).
In claim 1, lines 3-6, and line 11, the limitations “is prepared by injected a first liquid composition comprising docetaxel and ethanol into an infusion bag or bottle containing a second aqueous composition comprising serum albumin in a parenterally acceptable vehicle” and “is prepared within 24 hours,” respectively, are product-by-process limitations.
The final product of Sun appears to be identical to that set forth in the instant claims, regardless of how the composition was made. Therefore, absent evidence to the contrary, the manner in which the composition was made would have been a simple matter of design choice for the person of ordinary skill in the art at the effective filing date of the instant invention.
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), see MPEP 2113.
Product-by-Process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially identical is found and a prior art rejection is made, the burden shifts to the applicant to show a nonobvious difference. See above paragraph and MPEP 2113.
Moreover, Sun teaches a method for the preparation of its compositions comprising mixing an organic solution of docetaxel in a polar water-miscible organic solvent and a first aqueous solution containing human serum albumin to form a second aqueous solution, wherein the second aqueous solution is a clear aqueous solution (pg. 112, claim 119).
In claim 1, the limitations “for infusion” in line 1, “is administered by infusion to treating a patient diagnosed with a solid tumor. . .and neck cancer,” in lines 8-10, “wherein the dose of docetaxel is infused to said patient in need thereof is about 75 mg/m2,” in lines 11-12, and “prior to being infused to said patient,” in the last 2 lines, and “infusion” in claim 5, and the limitations of instant claims 2 and 6-12, are intended use limitations.
Thus, if the prior art composition is capable of performing the intended use, then it meets the limitations of the claim; the intended use of the composition is being considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. See MPEP 2112.01.
Since the composition of Sun is capable of performing the recited intended uses, these limitations are met.
Moreover, Sun teaches its composition for a) infusion/injection (pg. 24, lines 10-18; pg. 99, Example 18; pg. 105, Example 103); and b) the treatment of prostate, breast, non-small cell lung, gastric, and head and neck cancer (pg. 112, claim 18). Sun teaches its compositions as clear aqueous solutions for at least 3 hours (pg. 11, claim 15) and that an effective dose can be determined by reference to the prescribing information for docetaxel (pg. 55, lines 5-6).
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/081520 to Sun (published 2018, IDS of 08/19/2025).
Note: The composition of Sun appears to meet the structural limitations of the product-by-process limitations on instant claim 1. Assuming arguendo, it does not, the following rejection is applied.
Sun is applied as discussed above and incorporated herein.
While Sun teaches a composition comprising docetaxel, human serum albumin, ethanol and water, wherein the composition does not contain polysorbate 80, it differs from that of instant claim 1 in that it does not teach the composition as prepared within 24 hours prior to being infused to the patient. It additionally differs from that of instant claim 2 in that it does not teach the composition as prepared within 4 hours prior to being infused to a patient.
Sun teaches its compositions as clear for at least 2, 4, 3, 6, 8, 10, 12, 20, and 24 hours following preparation (pg. 6, lines 13-19; pg. 7, liens 11-22; pg. 9, lines 14-25; pg. 45, lines 24-30; pg. 111, claim 15).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to administer the composition of Sun within 24 hours or 4 hours following the composition’s preparation, to arrive at instant claims 1-2. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Sun teaches its compositions as clear for at least 4 and 24 hours, and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
As such, an ordinary skilled artisan would have been motivated to make such a selection to predictably arrive at a product that is stable and maximally non-degraded, prior to being administered, and thus, optimized for therapeutic effectiveness.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 5-6 of U.S. Patent No. 12,090,134 (PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘134 claims a pharmaceutical composition comprising docetaxel and human serum albumin , wherein the composition is a clear aqueous solution, wherein the docetaxel is in a water miscible organic solvent, wherein ethanol is the water miscible organic solvent, and wherein the human serum albumin is in an aqueous solution, i.e., a parenterally acceptable vehicle (claims 1, 3).
‘134 does not claim its compositions as containing polysorbate 80.
Regarding claims 3-4, while ‘134 does not claim a concentration of docetaxel or human serum albumin, an ordinary skilled artisan would have been motivated to modify the concentrations to arrive at the instantly claimed concentrations, to predictably achieve a composition effective to treat breast, non-small cell, prostate, gastric, and neck and neck cancer (claims 5-6 of ‘134), which are the same cancers taught by the instant claims as treated by its compositions.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II),
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 12-13 of U.S. Patent No. 11,419,842 (PTO-892) in view of WO 2018/081520 to Sun (published 2018, IDS of 08/19/2025).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘842 claims a pharmaceutical composition comprising docetaxel and human serum albumin, wherein the composition is a clear aqueous solution, wherein the human serum albumin in the composition is from commercial pharmaceutical human serum albumin solution for infusion, i.e., in a parenterally acceptable vehicle (claim 7).
While ‘842 claims a compositions comprising docetaxel, human serum albumin, a parenterally acceptable vehicle, it differs from that of instant claim 1 in that it does not teach ethanol.
Sun is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add ethanol as a carrier for docetaxel, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-‘842 and Sun are both directed toward clear, aqueous compositions for infusion comprising docetaxel and human serum albumin for the treatment of breast, non-small cell, prostate, gastric, and neck and neck cancer (claims 12-13 of ‘842),
-Sun teaches ethanol as a pharmaceutically acceptable carrier for docetaxel in such compositions.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a stable docetaxel and human serum albumin composition that is effective to treat breast, non-small cell, prostate, gastric, and neck and neck cancer.
Regarding claims 3-4, while ‘842 does not claim a concentration of docetaxel or human serum albumin, an ordinary skilled artisan would have been motivated to modify the concentrations to arrive at the instantly claimed concentrations, to predictably achieve a composition effective to treat breast, non-small cell, prostate, gastric, and neck and neck cancer (claims 12-13 of ‘842), which are the same cancers taught by the instant claims as treated by its compositions.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II),
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5, 7, 10-11 of U.S. Patent No. 12,128,022 (PTO-892) in view of WO 2018/081520 to Sun (published 2018, IDS of 08/19/2025).
‘022 claims a pharmaceutical composition comprising docetaxel and human serum albumin, wherein the composition is dissolved in an aqueous solution, wherein the human serum albumin in the composition is from commercial pharmaceutical human serum albumin solution for infusion, i.e., parenterally acceptable vehicle, wherein the composition is a clear aqueous solution (claims 5, 7).
While ‘022 claims a compositions comprising docetaxel, human serum albumin, a parenterally acceptable vehicle, it differs from that of instant claim 1 in that it does not teach ethanol.
Sun is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add ethanol as a carrier for docetaxel, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-‘022 and Sun are both directed toward clear, aqueous compositions for infusion comprising docetaxel and human serum albumin for the treatment of breast, non-small cell, prostate, gastric, and neck and neck cancer (claims 10-11 of ‘022),
-Sun teaches ethanol as a pharmaceutically acceptable carrier for docetaxel in such compositions.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a stable docetaxel and human serum albumin composition that is effective to treat breast, non-small cell, prostate, gastric, and neck and neck cancer.
Regarding claims 3-4, while ‘022 does not claim a concentration of docetaxel or human serum albumin, an ordinary skilled artisan would have been motivated to modify the concentrations to arrive at the instantly claimed concentrations, to predictably achieve a composition effective to treat breast, non-small cell, prostate, gastric, and neck and neck cancer (claims 10-11 of ‘022), which are the same cancers taught by the instant claims as treated by its compositions.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II),
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 19/325,311 (claim set dated 09/10/2025, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘311 claims a pharmaceutical formulation comprising a liquid composition comprising docetaxel, ethanol, human serum albumin, and a parenterally acceptable vehicle, wherein the formulation does not contain polysorbate 80, wherein the composition is prepared less than 24 hours prior to being administered to a patient (claims 1-3).
‘311 claims 0.1-20% w/v concentration of human serum albumin (claim 4).
‘311 claims 0.05-1mg/ml concentration of docetaxel (claim 7).
Regarding claim 5, while ‘311 does not claim this limitation, an ordinary skilled artisan would have reasonably expected the formulation of ‘311 to be a clear, aqueous solution since it teaches the same composition as instantly claimed. See MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8-10, 15, 17-21 of copending Application No. 18/387,327 (claim set dated 11/06/2023) in view of WO 2018/081520 to Sun (published 2018, IDS of 08/19/2025).
‘327 claims an aqueous pharmaceutical composition comprising docetaxel and human serum albumin, wherein the composition is a clear aqueous solution, wherein the composition comprises a pharmaceutically acceptable carrier, i.e., a parenterally acceptable vehicle (claims 1, 6, 8-10, 15, 17-19).
While ‘327 claims compositions comprising docetaxel, human serum albumin, and a pharmaceutically acceptable vehicle, it differs from that of instant claim 1 in that it does not teach ethanol.
Sun is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add ethanol as a carrier for docetaxel, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-‘327 and Sun are both directed toward clear, aqueous compositions comprising docetaxel and human serum albumin for the treatment of breast, non-small cell, prostate, gastric, and neck and neck cancer (claims 20-21 of ‘327),
-Sun teaches ethanol as a pharmaceutically acceptable carrier for docetaxel in such compositions.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a stable docetaxel and human serum albumin composition that is effective to treat breast, non-small cell, prostate, gastric, and neck and neck cancer.
Regarding claims 3-4, while ‘327 does not claim a concentration of docetaxel or human serum albumin, an ordinary skilled artisan would have been motivated to modify the concentrations to arrive at the instantly claimed concentrations, to predictably achieve a composition effective to treat breast, non-small cell, prostate, gastric, and neck and neck cancer (claims 20-21 of ‘327), which are the same cancers taught by the instant claims as treated by its compositions.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II),
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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/LAUREN WELLS/Examiner, Art Unit 1622
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