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 .
Status of Application
Applicant’s amendments of claim(s) 1, 2, 8, 35-37, 39-40, 44-45 in the reply filed on 04/22/2026 is acknowledged.
Applicant’s cancellation of claim(s) 9, 10, and 41 in the reply filed on 04/22/2026 is acknowledged.
Claims 1-8, 11, 35-40, and 44-45 are under examination.
Applicant's arguments, filed 04/22/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112
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.
Claim 2 is 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 2 has been amended to include the term “non-radioactive” to describe Lu-PSMA I&T. Neither the specification nor the claims provide basis for the inclusion of the limitation “non-radioactive” in claim 2. Therefore, claim 2 is held to contain new matter.
Claim Rejections - 35 USC § 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 (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.
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.
Responses to Applicant Amendments and Arguments
Claim(s) 1-2, 5-8, 35, 37-40, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over McCann et al. (US 11,129,912 B1, cited in the IDS filed on 10/14/2024).
McCann et al. (hereafter referred to as McCann) is drawn to 177Lu-PSMA I&T radiopharmaceuticals (title, abstract, specs, and claims). McCann teaches a 177Lu-PSMA I&T radiopharmaceutical in high purity possesses extended shelf life and teaches various synthetic methods, compositions, and treatments comprising 177Lu-PSMA I&T from the abstract on page 1.
As to claim 1, McCann teaches a pH range that is close to the claimed range at pH 4.2. In such cases, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05(I). With respect to pH of the composition, the examiner notes that the pH range of 4.5-7.0 taught by McCann is close to the claimed pH range of 3.5-4.2.
In the alternative to claim 1, generally differences in concentration (e.g. pH of the composition) between the claimed invention and prior art will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144(II)(A). Additionally, where 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. See MPEP 2144.05(II)(A). It would not have been inventive for the skilled artisan to have discovered the optimum or workable pH range and concentration of these components via routine experimentation.
As to claim 2, McCann teaches that the radiopharmaceutical composition is free of chemical impurities in an amount of not more than 0.5 weight % (pg 10, col 10, lines 23-26). The chemical impurities are anything that isn’t lutetium-177. Therefore, non-radioactive lutetium is included. And, the phrase not more than 0.5 weight % means ≤ 0.5 weight % which includes 0 weight %. The claimed range is < 6 µg of non-radioactive lutetium. The claimed range lies inside or overlaps the prior art range. The claimed non-radioactive lutetium range lies inside or overlaps the prior art non-radioactive lutetium range. In such instances where the claimed range lies inside or overlaps a prior art range, it establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 5, McCann teaches radiopharmaceutical compositions without ethanol (example 2, col 29, lines 19-61).
As to claim 6, McCann teaches a radioactivity with a range from at least 100 MBq/mL to at least 1000 MBq/mL (Col 22, lines 21-24). The claimed “radioactivity of about 0.5 GBq/mL” is about 500 MBq/mL which falls within the prior art range. The claimed radioactivity range lies inside the prior art radioactivity range in McCann (Col 22, lines 21-24). In such instances where the claimed range lies inside a prior art range, it establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 7, McCann teaches one or more ascorbate compounds, which was defined to include ascorbic acid (Col 19, line 38-40), in ranges from 5-120 mg/mL. The claimed “about 21 mg/mL to about 42.5 mg/mL ascorbic acid” falls within this range. The claimed ascorbate concentration range lies inside the prior art ascorbate concentration range. In such instances where the claimed range lies inside a prior art range, it establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 8, McCann teaches a radiopharmaceutical composition comprising the required components: 177Lu, PSMA I&T precursor, sodium acetate, hydrochloric acid, L-ascorbic acid, and specific activity less than or equal to 61 GBq in 6-8 mL of solution.
Regarding the lutetium-177 of claim 8, McCann teaches lutetium-177 (Col 29, lines 38-40). The non-specified claimed range of 177Lu enables values which overlap with the range taught by McCann. The claimed lutetium-177 range lies inside the prior art lutetium-177. In such instances where the claimed range lies inside a prior art range, it establishes a prima facie case of obviousness. See MPEP 2144.05(I).
Regarding the PSMA-I&T precursor of claim 8, McCann teaches approximately 424 µg/mL concentration range (Col 29, lines 30-34). The claimed range is similar to the prior art range of 463 µg/mL. Generally, differences in concentration (e.g. precursor concentration) between the claimed invention and prior art will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144(II)(A). Additionally, where 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. See MPEP 2144.05(II)(A). It would not have been inventive for the skilled artisan to have discovered the optimum or workable pH range and concentration of these components via routine experimentation.
Regarding the 4 mL 0.4 M sodium acetate of claim 8, McCann teaches an acetate solution may be used as a buffer for 177Lu-containing compositions (col 11, lines 14-21) and the use of a 0.4 M acetate solution for 177Lu-containing compositions (col 26, lines 56-57). McCann does not teach the volume of the acetate solution in the composition. Generally, differences in concentration or temperature between the claimed invention and prior art will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144(II)(A). Additionally, where 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. See MPEP 2144.05(II)(A). It would not have been inventive for the skilled artisan to have discovered the optimum or workable volume and concentration of these components via routine experimentation. Additionally, McCann teaches that the prior art may be scaled from a unit dose to a bulk solution (col 23, lines 35-39). Mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled. See MPEP 2144.04(IV)(A).
Regarding the 1.6 mL 0.05 M hydrochloric acid of claim 8, McCann teaches the use of a range from 0.05-0.4 N HCl (col 29, lines 29 and 40). The claimed concentration of 0.05 M HCl falls within the prior art range of 0.05-0.4N HCl. The claimed hydrochloric acid concentration lies inside the prior art hydrochloric acid concentration. In such instances where the claimed range lies inside a prior art range, it establishes a prima facie case of obviousness. See MPEP 2144.05(I). Additionally, the volume of the HCl used is a result of the scale. McCann teaches the use of sodium acetate and a person having ordinary skill in the art would optimize accordingly to achieve an expected success with the concentration of sodium acetate. Mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled. See MPEP 2144.04(IV)(A).
Regarding the about 150 µL 20% L-ascorbic acid in claim 8, McCann teaches L-ascorbic acid in a range of 99-247 mg/mL which is 9.9-24.5% w/w L-ascorbic acid (where the density of water is 1 g/mL) (col 26, lines 51-55). The claimed concentration falls within the prior art concentration range. The claimed L-ascorbic acid concentration range lies inside the prior art L-ascorbic acid range. In such instances where the claimed range lies inside a prior art range, it establishes a prima facie case of obviousness. See MPEP 2144.05(I). With respect to the volume, mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled. See MPEP 2144.04(IV)(A).
Regarding the specific activity ≤ 61 GBq in 6-8 mL in claim 8, McCann teaches a specific activity of 100-1000 MBq/mL, which is 0.1-10 GBq/mL. The claimed volume range of 6-8mL creates an upper limit specific activity range of ≤ 7.6-10.2 GBq/mL. The less than or equal establishes everything below this range is also within the scope of the claim. The claimed specific activity lies inside the prior art specific activity. In such instances where the claimed range lies inside a prior art range, it establishes a prima facie case of obviousness. See MPEP 2144.05(I). With respect to the volume, mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled. See MPEP 2144.04(IV)(A).
As discussed in detail above, McCann teaches radiopharmaceutical compositions comprising the required components: 177Lu, PSMA I&T precursor, sodium acetate, hydrochloric acid, L-ascorbic acid, and specific activity less than or equal to 61 GBq in 6-8 mL of solution. Therefore, the combined teachings of McCann render claim 8 prima facie obvious as combining prior art elements according to known methods would yield predictable results (MPEP 2143(i)(a)). A person of ordinary skill in the art would be motivated to combine McCann’s teachings as McCann teaches compositions comprising the required components are known in the art.
Regarding the pH of the solution that is about 4.2 or below in claim 36, McCann teaches a pH range of 4.5-7 (col 26, lines 52-67) that is close to the claimed range of about 4.2 or below. In such cases, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05(I).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the embodiments of composition of McCann to include the additional embodiments as taught by McCann because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of the combined embodiments. A person of ordinary skill in the art would have had a reasonable expectation of success in combining the embodiments because McCann teaches them as all being part of a radiopharmaceutical composition. The skilled artisan would have been motivated to combine the embodiments because they enable modular and adaptive radiopharmaceutical compositions for application.
As to claim 35, McCann teaches the general conditions of a radiopharmaceutical composition comprising 177Lu-PSMA I&T, ascorbic acid in solution suitable for administration to a human patient at least 48 hours after formulation (McCann, col 30, lines 19-53). As such, it would not have been inventive for the skilled artisan to have discovered the optimum or workable range and concentration of these components via routine experimentation. McCann teaches a pH range of 4.5-7.0 which is close to the claimed range of 3.5-4.2. In such cases, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05(I).
As to claim 37, McCann teaches 177Lu-PSMA I&T in a concentration from 10-500 µg/mL (col 23, lines 12-14). The concentration range with the range taught by McCann. In such cases, even a little overlap of ranges establishes a prima facie case of obviousness. See MPEP 2144.05(I). With respect to concentration of the 177Lu-PSMA I&T, the examiner notes that the concentration range of 10-500 µg/mL taught by McCann overlaps the claimed concentration range of about 5-15 µg/mL.
Regarding the ascorbic acid in claim 37, the ascorbic acid in a concentration range from about 10-50 mg/mL is taught by McCann. McCann teaches one or more ascorbate compounds, which was defined to include ascorbic acid (col 19, line 38-40), in ranges from 5-120 mg/mL. The claimed “about 10 mg/mL to about 50 mg/mL ascorbic acid” falls within this range. The claimed ascorbic acid concentration range lies inside the prior art ascorbic acid concentration range. In such instances where the claimed range lies inside a prior art range, it establishes a prima facie case of obviousness. See MPEP 2144.05(I).
Regarding the claimed pH range of 3.0-4.2, McCann teaches a pH range of 4.5-7.0 which is close to the claimed range of 3.5-4.2. In such cases, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05(I).
Regarding the composition is suitable for administration to a human subject at least 90 hours after formulation and has a radiochemical purity of at least 95% at the time of administration, McCann teaches. McCann teaches a radiochemical purity of at least 95% in a range from 3, 4, and 5 days after preparation (col 20, lines 5-10). The range of 3-5 days is equivalent to 72-120 hrs. The claimed range of at least 90 hours overlaps with the prior art range of at least 72-120 hours. In such cases, where the claimed range lies inside a prior art range, it establishes a prima facie case of obviousness. See MPEP 2144.05(I).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the embodiments of composition of McCann to include the additional embodiments as taught by McCann because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of the combined embodiments. A person of ordinary skill in the art would have had a reasonable expectation of success in combining the embodiments because McCann teaches them as all being part of a radiopharmaceutical composition. The skilled artisan would have been motivated to combine the embodiments because they enable modular and adaptive radiopharmaceutical compositions for application.
As to claim 38, McCann teaches a radiopharmaceutical composition with a radioactivity from 100-1,000 MBq/mL (col 9, lines 56-63). This lies within claimed range of less than 300 mCi which is less than 11,100 MBq. Since the prior art range lies fully within the range claimed, the claimed range is anticipated by McCann and claim 38 with all the limitations of claim 37 is rendered obvious to a person having ordinary skill in the art.
As to claim 39, the claimed ascorbic acid concentration range is 10-50 mg/mL. McCann teaches one or more ascorbate compounds, which was defined to include ascorbic acid (col 19, lines 38-40), in ranges from 5-120 mg/mL. The claimed about 10-50 mg/mL ascorbic acid falls within this range. The claimed ascorbic acid concentration range lies inside the prior art ascorbic acid concentration range. In such instances where the claimed range lies inside a prior art range, it establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 40, the claimed 70-130% of an amount of radioactive content, interpreted by the examiner to mean 70-130% of a value within the range of about 5-15 µg/mL of 177Lu-PSMA I&T after formulation, gives a possible range from 3.5-19.5 µg/mL of 177Lu-PSMA I&T in solution after formulation. McCann teaches 177Lu-PSMA I&T in a concentration from 10-500 µg/mL (col 23, lines 12-14). The concentration range with the range taught by McCann. In such cases, even a little overlap of ranges establishes a prima facie case of obviousness. See MPEP 2144.05(I). With respect to concentration of the 177Lu-PSMA I&T, the examiner notes that the concentration range of 10-500 µg/mL taught by McCann overlaps the possible claimed concentration range of 3.5-19.5 µg/mL.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the embodiments of composition of McCann to include the additional embodiments as taught by McCann because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of the combined embodiments. A person of ordinary skill in the art would have had a reasonable expectation of success in combining the embodiments because McCann teaches them as all being part of a radiopharmaceutical composition. The skilled artisan would have been motivated to combine the embodiments because they enable modular and adaptive radiopharmaceutical compositions for application.
As to claim 44, McCann teaches a radiochemical purity of at least 97% in a range from 3, 4, and 5 days after preparation (col 20, lines 5-10). While the prior art time range lists times beyond 0 hours, the radiochemical purity decreases with time and so, in reverse, includes 0 hour. The claimed radiochemical purity range overlaps the prior art radiochemical purity range. In such instances where the claimed range lies inside a prior art range, it establishes a prima facie case of obviousness. See MPEP 2144.05(I). Regarding the pH, McCann teaches a pH range of 4.5-7.0 which is close to the claimed range of 3.5-4.2. In such cases, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05(I).
Regarding administration to a human subject at least 90 hours after formulation, McCann teaches administration to a human subject for at least 72-120 hours (col 20, lines 5-10). The claimed range of at least 90 hours overlaps with the prior art range of at least 72-120 hours. In such cases, where the claimed range lies inside a prior art range, it establishes a prima facie case of obviousness. See MPEP 2144.05(I).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the embodiments of composition of McCann to include the additional embodiments as taught by McCann because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of the combined embodiments. A person of ordinary skill in the art would have had a reasonable expectation of success in combining the embodiments because McCann teaches them as all being part of a radiopharmaceutical composition. The skilled artisan would have been motivated to combine the embodiments because they enable modular and adaptive radiopharmaceutical compositions for application.
Response to Arguments
Applicants argue that McCann does not teach or suggest a radiopharamaceutical composition of 177Lu-PSMA I&T and ascorbic acid at a pH of 4.2 or less as claimed. The applicants acknowledge that McCann teaches a pH of 4.5-7. The Applicants argue that McCann fails as prior art since the pH range disclosed in the prior art are in opposite directions and there is no overlap between them.
Respectfully, the applicants’ arguments are not persuasive. With respect to range directionality, the examiner notes that pH ranges do not have direction to them. Ranges merely state values contained whether bounded or unbounded. With respect to the amended pH range, the examiner acknowledges that the applicant amendment changes the scope of the claim range to lie outside of the range recited by McCann. However, similar to when ranges overlap, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) and MPEP 2144.05(I).
Additionally, the applicants argue the lower pH range “improves stability of the radiopharmaceutical composition against radiolytic decomposition, thus improving the shelf life of the composition.” The Applicants argue that since McCann does not provide the same rationale for their stability, there is no case for optimization of McCann’s pH range. And, applicants argue the amended pH range are outside McCann’s evaluated pH range.
Respectfully, the applicants’ arguments are not persuasive. In the case of McCann’s composition, the composition recites similar levels of purity and longer stability compared to the claimed composition. Therefore, adjustments to the pH range of the prior art would be expected to still give excellent stability for a similar length of time. Additionally, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) and MPEP 2144.05(I).
Applicant has amended claim 2 to include “non-radioactive lutetium”. In view of the amendments changing the scope of the claim, the rejection is correspondingly amended with the prior art of McCann.
The rejections are maintained.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over McCann et al. (US 11,129,912 B1, cited in the office action filed on 10/14/2024) in view of Banerjee; S. (Lutetium-177 Therapeutic Radiopharmaceuticals: Linking Chemistry, Radiochemistry, and Practical Applications, Chem. Rev. 2015, 115, 2934-2974, cited in the IDS filed on 10/07/2025). The teachings of McCann as applied in the previous rejections are incorporated in this rejection.
As to claim 3, McCann teaches a diethylentriaminepentaacetic acid (DTPA) chelator for 177Lu-PSMA I&T.
McCann does not teach ethylenediaminetetraacetic acid (EDTA).
Banerjee et al. (hereafter referred to as Banerjee) discloses common chelating agents, including EDTA, used for 177Lu radiopharmaceuticals (Fig 4).
Banerjee discloses EDTA (pg 2941, Fig 4 and Table 4).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the embodiments of composition of McCann to include the additional embodiments as taught by Banerjee because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of the combined embodiments. A person of ordinary skill in the art would have had a reasonable expectation of success in combining the embodiments of McCann with Banerjee because they are both drawn to chelators useful in radiopharmaceutical compositions. The skilled artisan would have been motivated to combine the embodiments because the chelators are well-known and are useful in clinical settings.
Alternatively, as to the chelator, while McCann does not disclose the same chelator, the function of McCann chelator and the claimed chelator serve the same purpose: in such instances swapping similar features that serve the same purpose establishes a prima facie case of obviousness. See MPEP 2143(I)(B). With regard to the chelator, McCann teaches the use of a sequestering agent suitable to remove uncomplexed lutetium-177, such as diethylentriaminepentaacetic acid (DTPA) (col 23, lines 10-14). This sequestering agent is a chelator which can have the same function as EDTA as stated by claimed art (specifications, paragraph [0077], [00124], [00125], and [00130]). A simple substitution of one known element for another would have led a person of ordinary skill in the art to obtain predictable results. The prior art contained DPTA with the general conditions of claim 1, the substituted EDTA is a stated substitute as cited above. So, one of ordinary skill in the art could have substituted EDTA for DTPA and the results of the substitution would have been predictable.
Further as to claim 3, the concentration range of EDTA lies inside ranges disclosed by the prior art as of the concentration range of DTPA in McCann (col 23, lines 10-14). In such instance where the claimed range lies inside a prior art range, it establishes a prima facie case of obviousness. See MPEP 2144.05(I). With regard to the concentration of the chelator, the examiner notes that the 0.01 to 0.50 mg/mL (which is 10-50 µg/mL) taught by McCann contains the claimed range of 13-18 µg/mL.
Response to Arguments
Applicants argue that McCann fails to teach or suggest a composition comprising 177Lu-OSMA I&T solution with a pH of 3.5 to 4.2.
Respectfully, the applicants’ arguments are not persuasive. With respect to the amended pH range, the examiner acknowledges that the applicant amendment changes the scope of the claim range to lie outside of the range recited by McCann. However, similar to when ranges overlap, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) and MPEP 2144.05(I).
Applicants argue that Banerjee fails to overcome the deficiencies of McCann. With respect to the amended pH range, Banerjee is not combined with McCann to address pH. McCann renders the amended pH range prima facie obvious. See MPEP 2144.05(I).
Additionally, applicants argue Banerjee not only does not teach or suggest the claimed low pH range but also does not teach or suggest the composition having high-purity at ≥ 90 hours after formulation. Respectfully, the applicants’ arguments are not persuasive. Banerjee is not combined with McCann to teach the high purity but the EDTA. In the case of McCann’s composition, the composition recites similar levels of purity and longer stability compared to the claimed composition. Therefore, adjustments to the pH range of the prior art would be expected to still give excellent stability for a similar length of time. Additionally, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) and MPEP 2144.05(I).
The rejection is maintained.
Claims 4, 11, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over McCann et al. (US 11,129,912 B1, Cited in the IDS filed on 10/14/20204) in view of Erion et al. (WO 2008009444 A1). The teachings of McCann as applied in the previous rejection are incorporated in this rejection.
Erion et al. (hereafter referred to as Erion) is drawn to use of ethanol to stabilize radio-labelled pharmaceutical compositions as of Erion, title and abstract.
As to claim 4, McCann teaches that ethanol may be used in radiopharmaceutical compositions (col 22, lines 34-40). See the rejection of the radiopharmaceutical composition above. Further, McCann does not teach the amount of ethanol to be used in the radiopharmaceutical composition.
Erion teaches the use of ethanol “…in a quantity sufficient to prevent radiolysis…” to stabilize radiopharmaceutical compositions as of Erion’s claim 7. Erion further teaches a radiopharmaceutical composition containing 1-20% v/v (page 6, line 15-17). “In general, the quantity of ethanol in the injection liquid, is 1 to 20 % v/v, preferably approx. 5 to 20% v/v. Generally, approx. 10% v/v of ethanol is sufficient for an adequate stabilization.”
The claimed “about 35 µL to about 40 µL ethanol per mL of solution” is equivalent to about 3.5-4% v/v in the solution. The claimed ethanol range lies within the prior art range. Therefore, it would have been prima facie obvious for one of ordinary skill in the art to have added ethanol in ranges used in Erion to the ascorbic acid in McCann to the radiopharmaceutical composition in order to have achieved predictable results (improved stability and shelf life such as the radiopharmaceutical composition of McCann) is prima facie obvious. See MPEP 2144.05(I).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the embodiments of composition of McCann to include the additional embodiments as taught by Erion because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of the combined embodiments. A person of ordinary skill in the art would have had a reasonable expectation of success in combining the embodiments because McCann and Erion teach them as all being part of a radiopharmaceutical compositions. The skilled artisan would have been motivated to combine the embodiments because ethanol is a common solvent in the art in formulations.
As to claim 11, the result of adding ethanol in the ranges discussed in Erion to the radiopharmaceutical concentration of McCann rationale from claim 4 is also applicable here. The claimed ethanol amount of 0.75 mL to 6 to 8 mL of solution which has a range the overlaps with the range discussed in Erion. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
McCann et al. (hereafter referred to as McCann) is drawn to 177Lu-PSMA I&T radiopharmaceuticals (title, abstract, specs, and claims). McCann teaches a 177Lu-PSMA I&T radiopharmaceutical in high purity possesses extended shelf life and teaches various synthetic methods, compositions, and treatments comprising 177Lu-PSMA I&T from the abstract on page 1.
Erion et al. (hereafter referred to as Erion) is drawn to use of ethanol to stabilize radio-labelled pharmaceutical compositions as of Erion, title and abstract.
As to claim 45, McCann and Erion teach a radiopharmaceutical composition comprising the required components: 177Lu-PSMA I&T solution for injection, 177Lu-PSMA I&T (about 5-15 µg/mL), ascorbic acid (about 10-50 mg/mL), ethanol (about 1-10 % (v/v), a chelating agent (about 0.001-0.15 % (w/w) of the total weight of the radiopharmaceutical composition, and a solution pH (about 3-4.2)
Regarding the 177Lu-PSMA I&T in an amount from about 5-15 µg/mL in claim 45, McCann teaches Lu-PSMA I&T in a concentration from 10-500 µg/mL (col 23, lines 12-14). The concentration range with the range taught by McCann. In such cases, even a little overlap of ranges establishes a prima facie case of obviousness. See MPEP 2144.05(I). With respect to concentration of the Lu-PSMA I&T, the examiner notes that the concentration range of 10-500 µg/mL taught by McCann is similar to the claimed concentration range of 5-15 µg/mL.
Regarding the ascorbic acid in a concentration from about 10-50 mg/mL in claim 45, McCann teaches one or more ascorbate compounds, which was defined to include ascorbic acid (col 19, line38-40), in ranges from 5-120 mg/mL. The claimed “about 10 mg/mL to about 50 mg/mL ascorbic acid” falls within this range. The claimed ascorbic acid concentration range lies inside the prior art ascorbic acid concentration range. In such instances where the claimed range lies inside a prior art range, it establishes a prima facie case of obviousness. See MPEP 2144.05(I).
Regarding a chelating agent in an amount from about 0.001-0.15 % (w/w) of the total weight of the radiopharmaceutical composition in claim 45, McCann teaches this (col 23, lines 10-14). The claimed range of 0.001-0.15 % (w/w) overlaps with the prior art range of 0.01-0.50 mg/mL, which is roughly about 0.01-0.5 % (w/w). In such cases, overlap of ranges establish a prima facie case of obviousness. See MPEP 2144.05(I). With respect to the chelating agent concentration range, the examiner notes that the concentration range taught by McCann overlaps with the claimed concentration range.
Regarding the pH of the solution that is about 4.2 or below in claim 36, McCann teaches a pH range of 4.5-7 (col 26, lines 52-67) that is close to the claimed range of about 4.2 or below. In such cases, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05(I).
Within claim 45, the radiopharmaceutical composition comprises ethanol in a concentration from about 1-10 % (v/v).
McCann does not teach a concentration range for ethanol in a radiopharmaceutical composition.
Erion teaches the use of ethanol for stabilizing radiopharmaceutical compositions in a concentration of 1-20% v/v (page 6, line 15-17). The claimed range 1-10 % (v/v) lies within the prior art range. The claimed ethanol concentration range lies inside the prior art ethanol concentration range. In such instances where the claimed range lies inside a prior art range, it establishes a prima facie case of obviousness. See MPEP 2144.05(I).
Therefore, regarding claim 45, it would have been prima facie obvious for one of ordinary skill in the art to have added ethanol in ranges used in Erion to the ascorbic acid in McCann to the radiopharmaceutical composition in order to have achieved predictable results (improved stability and shelf life such as the radiopharmaceutical composition of McCann) is prima facie obvious. See MPEP 2144.05(I).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the embodiments of composition of McCann to include the additional embodiments as taught by Erion because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of the combined embodiments. A person of ordinary skill in the art would have had a reasonable expectation of success in combining the embodiments because McCann and Erion teach them as all being part of a radiopharmaceutical composition. The skilled artisan would have been motivated to combine the embodiments because of the necessity to control the amount of ethanol in a clinical setting.
Response to Arguments
The applicants argue that McCann fails to teach or suggest 177Lu-PSMA I&T solution with a pH of 4.2 or lower. And, the applicants argue Erion fails to overcome the deficiencies of McCann since Erion does not disclose any pH values.
Respectfully, the applicants’ arguments are not persuasive. Erion is combined with McCann to teach ethanol and is not used to teach the pH. With respect to the amended pH range, the examiner acknowledges that the applicant amendment changes the scope of the claim range to lie outside of the range recited by McCann. However, McCann renders the amended range prima facie obvious. Similar to when ranges overlap, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) and MPEP 2144.05(I).
The rejections are maintained.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over McCann et al. (US 11,129,912 B1, cited in the IDS filed on 10/14/2024) in view of Erion et al. (WO 2008009444 A1) in further view of Vyas et al. (Vyas, M., Fagan, J., Lim, R., & Garett, N. (2020, October). Lutetium-177-PSMA I&T for progressing metastatic castrate-resistant prostate cancer: A single NZ centre experience. Paper presented at the New Zealand Society for Oncology-2020, Auckland, New Zealand).
As to claim 36, the examiner notes the claim has the following required components: 177Lu-PSMA I&T (enough for intended use), ascorbic acid (210-700 mg), ethanol (274-706 mg), and pH (about < 4.2).
Regarding the 177Lu-PSMA I&T in sufficient amounts of radioactivity for intended use in claim 36, McCann teaches a 177Lu-PSMA I&T solution for an intended use (e.g. injection)
Regarding the ascorbic acid (210-700 mg) in claim 36, McCann teaches ascorbic acid in concentrations around 162 mg/mL (example 2, col 29, lines 17-55). Concentration falls within the possible claimed concentration range of the ascorbic acid. Additionally, while the prior art does not teach ascorbic acid in terms of amount used but concentration used, the ranges overlap when 2 mL of the prior art solution is obtained. In such cases, overlapping or even similar ranges establish a prima facie case of obviousness. See MPEP 2144.05(I).
Regarding administration to a human subject at least 90 hours after formulation, McCann teaches administration to a human subject for at least 72-120 hours (col 20, lines 5-10). The claimed range of at least 90 hours overlaps with the prior art range of at least 72-120 hours. In such cases, where the claimed range lies inside a prior art range, it establishes a prima facie case of obviousness. See MPEP 2144.05(I).
Regarding the ethanol (about 274-706 mg) in solution in claim 36, McCann teaches the use of ethanol in radiopharmaceutical compositions (col 22, lines 34-40).
McCann does not teach amounts of ethanol to be used in the radiopharmaceutical composition.
Erion is drawn to the use of ethanol for stabilizing radiopharmaceutical compositions, see rationale discussed above. Erion teaches a radiopharmaceutical composition containing 1-20% v/v (page 6, line 15-17). “In general, the quantity of ethanol in the injection liquid, is 1 to 20 % v/v, preferably approx. 5 to 20% v/v. Generally, approx. 10% v/v of ethanol is sufficient for an adequate stabilization.” In the claimed ethanol amount of 274-706 mg, this range can be similar to the prior art range in a bulk solution for injection. If the bulk solution is 100 mL, then the claimed ethanol range lies within or similar to the prior art range. Therefore, it would have been prima facie obvious for one of ordinary skill in the art to have added ethanol in ranges used in Erion to the ascorbic acid in McCann to the radiopharmaceutical composition in order to have achieved predictable results. See MPEP 2144.05(I).
Regarding the pH of the solution that is about 4.2 or below in claim 36, McCann teaches a pH range of 4.5-7 (col 26, lines 52-67) that is close to the claimed range of about 4.2 or below. In such cases, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05(I).
Regarding the low levels of hematotoxic and nephrotoxic toxicity in claim 36, the examiner notes this speaks to the intended use. Since the composition has the components and characteristics of the prior art, it has the properties as well. See MPEP 2112.01(III).
Regarding the prostate-specific antigen decline is more than about 50% in claim 36, the examiner notes that this speaks to intended use. Since the composition has the components and characteristics of the prior art, it has the properties as well. See MPEP 2112.01(III).
Alternatively, to the contingent clause interpretation, McCann teaches the radiopharmaceutical composition of claim 36, McCann does not teach the PSA decline of more than about 50%.
Vyas et al. (hereafter referred to as Vyas) is drawn to the use of lutetium-177-PSMA I&T for progressing metastatic castrate-resistant prostate cancer (title). Vyas teaches various radioisotopes and PSMA ligands used (page 5). Vyas teaches 177Lu-PSMA I&T demonstrating prostate-specific antigen decline that is more than about 50% (page 16).
Vyas teaches 177Lu-PSMA I&T demonstrating prostate-specific antigen decline that is more than about 50% (page 16).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the embodiments of composition of McCann and Erion to include the additional embodiments as taught by Vyas because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of the combined embodiments. A person of ordinary skill in the art would have had a reasonable expectation of success in combining the embodiments because McCann, Erion, and Vyas teach them as all being part of a radiopharmaceutical compositions. The skilled artisan would have been motivated to combine the embodiments because the clinical effect of the composition is useful to design in a clinical setting.
Response to Arguments
The applicants argue that McCann and Erion fails to teach or suggest a composition of 177Lu-PSMA I&T solution with a pH of 4.2 or lower. And, the applicants argue Vyas fails to overcome the deficiencies of McCann and Erion since Vyas does not teach or suggest any pH values of the composition.
Respectfully, the applicants’ arguments are not persuasive. Vyas is combined with McCann and Erion to teach PSA decline and is not used to teach the pH. With respect to the amended pH range, the examiner acknowledges that the applicant amendment changes the scope of the claim range to lie outside of the range recited by McCann. However, McCann renders the amended range prima facie obvious. Similar to when ranges overlap, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) and MPEP 2144.05(I).
The rejection is maintained.
Non-Statutory 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.
Co-pending Application No. 19/063,049
Claims 1-8, 11, 35-40, and 44-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7, 23, 24, 25, and 29 of co-pending application No. 19/063,049 in view of McCann; Banerjee; Erion and Vyas.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
Instant claims 1, 3, 5, 7, 10, and 35 are taught by conflicting claims in co-pending application No. 19/063,049 claims 1, 3, 5-7, 23 24, 25, and 29.
Instant claim 1 is drawn to a radiopharmaceutical composition comprising 177Lu-PSMA I&T, ascorbic acid at a pH of 3.5 to 3.5 in solution suitable for human use at least 90 hours after formulation and with a radiochemical purity of 95% or greater at administration.
Conflicting claim 1 teaches a 177Lu-PSMA I&T composition suitable for administration to a human, conflicting claim 3 teaches a radiochemical purity of 95% or greater to at least 120 hours after formulation, conflicting claims 23 and 24 teach ascorbic acid; and, conflicting claim 7 teaches a composition pH from 3.5-4.5.
Instant claim 3 is drawn to disodium EDTA concentration of 13-18 µg/mL.
Conflicting claim 25 teaches the use of DTPA which serves the same purpose as EDTA and would be used to make obvious the use of EDTA.
Instant claim 5 is drawn to no inclusion of ethanol.
Conflicting claims 1, 7, 24, and 29 demonstrate that ethanol does not need to be included.
Instant claim 7 is drawn to a composition with ascorbic acid with concentrations from about 21-42.5 mg/mL.
Conflicting claim 24 state the use of ascorbic acid at a concentration from at least 28 mg/mL. The ranges overlap and the two claims would be held obvious over each other.
Instant claim 35 is drawn to a radiopharmaceutical composition comprising 177Lu-PSMA I&T and ascorbic acid with a solution pH of 3.5-4.5 suitable for injection and suitable for administration more than 48 hours after formulation.
Conflicting claim 1 teaches a 177Lu-PSMA I&T composition suitable for administration to a human, conflicting claim 3 teaches a radiochemical purity of 95% or greater to at least 120 hours after formulation, conflicting claims 23 and 24 teach ascorbic acid; and, conflicting claim 7 teaches a composition pH from 3.5-4.5.
However, the claims of 19/063,049 do not expressly teach the claim 2 amount of 177Lu-PSMA I&T, ethanol amounts in claims 4, 11, 36, 37, and 45, the radioactivity of claim 6, the amounts materials used to make a radiopharmaceutical composition in claim 8, nor the ascorbic acid concentration in claim 9 for that composition of claim 8.
As noted in the current rejections above, the teachings of McCann render obvious claims 1-2, 5-8, 35, 37-40, and 44. The combined teachings of McCann and Banerjee render obvious claim 3. The combined teachings of McCann and Erion render obvious claims 4, 11 and 45. The combined teachings of McCann, Erion and Vyas render obvious claim 36.
As claims 1, 3, 7, 23, 24, 25, and 29 of co-pending application No. 19/063,049 and the teachings of McCann, Banerjee , Erion, and Vyas all teach radiopharmaceutical compositions, it would have been obvious to combine the claims 1, 3, 7, 23, 24, 25, and 29 of co-pending application No. 19/063,049 with McCann, Banerjee, Erion and Vyas because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of the claimed radiopharmaceutical composition.
Co-Pending Application No. 18/791,300
Claims 1-8, 11, 35-40, and 44-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-7, 20-22, and 30 of copending application No. 18/791,300 in view of McCann; Banerjee; Erion and Vyas.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
Instant claims 1, 3, 5, 7, and 35 are taught by conflicting claims in co-pending application No. 18/791,300 claims 1, 3, 5-7, 20-22, and 30.
Instant claim 1 is drawn to a radiopharmaceutical composition comprising 177Lu-PSMA I&T, ascorbic acid at a pH of 3.5 to 4.5 in solution suitable for human use at least 90 hours after formulation and with a radiochemical purity of 95% or greater at administration.
Conflicting claim 1 teaches 177Lu-PSMA I&T suitable for administration to humans, conflicting claims 20 and 21 teach ascorbic acid, conflicting claims 4-7 teach a pH range including 3.5-4.5, conflicting claim 3 teaches administration to a human patient in need thereof for at least 90 hours after formulation, and conflicting claims 27 and 30 teach a composition with a radiochemical purity of 95% or greater.
Instant claim 3 is drawn to 13-18 µg/mL of EDTA for the radiopharmaceutical composition.
Conflicting claim 22 teaches the use of DTPA, a chelator for the same purpose. The specifications further show that DTPA and EDTA may be used in alternative form.
Instant claim 7 is drawn to 21-42.5 mg/mL ascorbic acid for the radiopharmaceutical composition.
Conflicting claim 20 teaches 10-50 mg/mL ascorbic acid. The instant claim range lies fully within the conflicting claim 20 range.
Instant claim 35 is drawn to a 177Lu-PSMA I&T solution for injection with a pH of 3.5-4.5 and suitable for administration more than 48 hours after formulation.
Conflicting claim 1 teaches 177Lu-PSMA I&T suitable for administration, conflicting claims 20 and 21 teach ascorbic acid, conflicting claims 4-7 teach a pH range including 3.5-4.5, conflicting claim 3 teaches administration in need thereof for at least 48 hours after formulation.
Regarding instant claims 2, 6, 8, 37, 38, 39, 40, and 44, co-pending application 18/791,300 teaches the radiopharmaceutical composition as discussed above.
However, the conflicting patent application does not expressly teach the limitations of instant claims 2, 6, 8, 37, 38, 39, 40, and 44.
As noted in the current rejections above, the combined teachings of McCann render obvious claims 1-2, 5-8, 35, 37-40, and 44. The combined teachings of McCann and Banerjee render obvious claim 3. The combined teachings of McCann and Erion render obvious claims 4, 11 and 45. The combined teachings of McCann, Erion and Vyas render obvious claim 36.
As claims 1, 3, 5-7, 20-22, and 30 of copending application No. 18/791,300 and the teachings of McCann, Banerjee , Erion, and Vyas all teach radiopharmaceutical compositions, it would have been obvious to combine the claims 1, 3, 5-7, 20-22, and 30 of copending application No. 18/791,300 with McCann, Banerjee, Erion, and Vyas because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of the claimed radiopharmaceutical composition.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 Evan M Lewoczko whose telephone number is (571)272-9830. The examiner can normally be reached Monday-Friday 9-5PM.
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/EVAN M LEWOCZKO/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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