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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Election/Restrictions
Applicant’s election in the reply filed on 09/05/2025, is acknowledged. Because applicant 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)).
Applicant provided complaint species of immunotherapeutic agent: gemcitabine.
Examiner found prior art on applicant’s elected species, therefore Markush search was not extended to other species according to Markush search practices.
Claim 31 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/05/2025.
Claims 1-19, and 21-29 are examined in this office action.
Current Status of 18/016,768
This office action is in response to the amended claims on 09/05/2025.
Claims 1-5, and 21-23 are original; and claims 6-19 and 24-29 are previously presented; and claim 31 is withdrawn.
Claims 1-19, and 21-29 are examined on merits.
Priority
The effective filing date is 07/31/2020 since the instant claims find support in provisional application no. 63/059,726.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 01/18/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 6 and 18-19 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Claim 6 recites “wherein the first treatment cycle is 28 days”. There is insufficient antecedent basis for “the first treatment cycle is 28 days” in claim 1. Claim 1 does not contain the limitation “first treatment cycle”. As drafted, “the first treatment cycle” in claim 6 renders the metes and bounds of claim 6 undefined. Thus claim 6 is indefinite.
Claim 18 recites “wherein the anticancer agent is chemotherapy”. There is insufficient antecedent basis for “anticancer agent” in claim 1. Claim 1 does not contain the limitation “anticancer agent”. As drafted, “the anticancer agent” in claim 18 renders the metes and bounds of claim 18 undefined. Thus claim 18 is indefinite.
Claim 19 is also rejected for depending on rejected claim 18, without further remedying the rationale underpinning the basis for rejecting claim 18.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6 and 18-19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Dependent claim 6 refers to “first treatment cycle” of claim 1, but claim 1 does not have “first treatment cycle” as limitation. Thus claim 6 fails to further limit independent claim 1, since claim 1 has no limitations drawn to “first treatment cycle”. Thus claim 6 is rejected under 35 U.S.C. 112(d).
Dependent claim 18 refers to “anticancer agent” of claim 1, but claim 1 does not have “anticancer agent” as limitation. Therefore claim 18 fails to further limit independent claim 1, since claim 1 has no limitations drawn to “anticancer agent”. Thus claim 18 is rejected under 35 U.S.C. 112(d).
Claims 19 are also rejected under 35 U.S.C. 112(d) because they refer back to claim 18 but do not remedy the bases for the rejection of claim 18.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
Claims 1-4, 7-8 and 21-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kilmberg (U.S. 2005/0090451 A1)
Klimberg teaches a method of treating a solid tumor in a subject in need thereof (Para [0256) and Para [0257] comprising: administering a therapeutically effective amount of glutamine to the subject with 30gm glutamine/day, thus anticipating claims 1. Klimberg teaches the method of claim 1, further comprising administering one or more treatment cycles of a therapeutically effective amount of anticancer agent, an immunotherapeutic agent, or radiation therapy (Para [0258]) anticipating claim 2. Klimberg further teaches administering the glutamine about 3 days to 2 weeks (claims 3 and 24) and 1 week (claims 4 and 25) prior to initiating the first treatment cycle of the anticancer agent, the immunotherapeutic agent, or radiation therapy (Para (0258]) anticipating claims 21 and 3-4. Klimberg teaches the method of using glutamine (examiner interprets glutamine to be mixture of both L-glutamine and D-Glutamine, using BRI) thus anticipating claims 7-8 and 22-23.
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.
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 1-19, and 21-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Kilmberg (US 2005/0090451 A1)
In view of
Qin et al. (Molecular Cancer (March 2nd, 2020) 19:50)
In further view of
Gaurav K, et.al (Glutamine: A novel approach to chemotherapy-induced toxicity. Indian J Med Paediatr Oncol. 2012 Jan;33(1):13-20).
In further view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
1. Determining the scope and contents of the prior art.
Klimberg et.al teaches claims 1-4, 7-8 and 21-25 (see 102 rejection above).
Qin et.al teaches gemcitabine as chemotherapy (anticancer agent for treating pancreatic cancer (partially teaching claims 18-19, 28-29) by interfering with DNA synthesis and block cancer cell cycle progression (page 8, column 1, paragraph 2, section title “chemoresistance and metabolism”). Qin et.al. further teaches Kras mutated pancreatic cancer (page 9 column 1) is also a solid tumor (page 11 column 1) (claims 15-17) and can become chemoresistance to long term use of gemcitabine (page 8, 2nd column, last paragraph).
Gauruv et. al. teaches glutamine will enhance the selectivity of antitumor drugs by protecting normal tissues from and possibly sensitizing tumor cells to radiation-induced and chemotherapy treatment-related injury tumor (page 16, section “Glutamine: Role in increasing selectivity of chemotherapeutic agents”).
2. Ascertaining the differences between the prior art and the claims at issue.
Klimberg et.al does not teach the dosage of glutamine administered in claims 9-14, 26-27 and 29. Klimberg further does not teach a method of administering glutamine and gemcitabine to Kras mutant pancreatic cancer solid tumor.
Qin et.al. does not teach a method of administering glutamine and gemcitabine to Kras mutant pancreatic cancer solid tumor.
Gaurav et.al does not teach method of administering glutamine and gemcitabine to Kras mutant pancreatic cancer solid.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing treatment for chemoresistance solid tumor of pancreatic cancer with Kras Mutant and is looking to improve the outcome of the treatment.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Glutamine is known in the art to treat solid tumor (Klimberg et.al paragraph [0258]). It is also known in the art glutamine can enhance the selectivity of antitumor drugs by protecting normal tissues from and possibly sensitizing tumor cells to radiation-induced and chemotherapy treatment-related injury tumor (Gaurav et.al. page 16, section “Glutamine: Role in increasing selectivity of chemotherapeutic agents”). Moreover, solid tumor of pancreatic cancer with Kras mutant (Qin page 11 column 1) is treated with gemcitabine is also known in the art (Qin et.al. page 8, column 1, paragraph 2, section title “chemoresistance and metabolism”) but can become chemoresistance to long term use of gemcitabine (Qin et.al. page 8, 2nd column, last paragraph). Therefore, artisan skilled in the art would be motivated to treat solid tumor of pancreatic cancer (Kras mutant) (Qin page 11 column 1) with glutamine since glutamine is known to treat solid tumor (Klimberg et.al paragraph [0258]) thus teaching claims 15-16. Furthermore, a person skilled in the art would be motivated to use glutamine (Klimberg et.al paragraph [0258]) with anticancer agent, gemcitabine for chemotherapy to treat solid tumor of pancreatic cancer with Kras mutant (Qin page 11 column 1) since combination of glutamine with gemcitabine is expected to treat pancreatic cancer better or same as gemcitabine. Moreover, glutamine will enhance the selectivity of antitumor drugs by protecting normal tissues from and possibly sensitizing tumor cells to radiation-induced and chemotherapy treatment-related injury tumor (page 16, section “Glutamine: Role in increasing selectivity of chemotherapeutic agents”) therefore is expected to reduce chemoresistance to gemcitabine. Therefore, it would be obvious for a person skilled in the art to combine the teaching of Klimberg et. al and Qin et.al to with Gaurav et.al to treat solid tumor of pancreatic cancer with Kras mutant, thus teaching all the elements of claims 1-4, 7-8, 21-26.
Claims 5-6, 9-14, 26-27 and 28-29 are directed to dosage and frequency of the dosage. Claims 5-6, 9-14 and 26-27 are directed to the amount of glutamine administered and claims 28-29 are directed to amount and frequency of gemcitabine administered to patients. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50). Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Applicants are asked to provide evidence of secondary considerations, such as surprising/unexpected results, that encompass the full scope of independent claims 1 and 21, in order to mitigate the chance that future obviousness rejections can be made.
Conclusion
No claims are allowable as written.
Please note Qin et.al teaches species paclitaxel and (nab)paclitaxel used for treating solid pancreatic tumor of Kras mutant (Qin et.al. page 8, column 1, paragraph 2, section title “chemoresistance and metabolism”), therefore 103 rejections for gemcitabine can also be made with species paclitaxel and (nab)paclitaxel when the Markush search is eventually extended.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625