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 .
Withdrawn Objections/Rejections
35 U.S.C. 101 rejection on claims 3 and 10-21 based on the claims being directed to a judicial exception is withdrawn, because applicant amended the claim 3 to recite an active step.
35 U.S.C. 101 rejection is maintained over claims 4-9
35 U.S.C.112 (a) lack of enablement rejection on claims 1-21 was modified to scope of enablement, because of the amendments to claim 1.
35 U.S.C. 102 rejection based on prior art was modified, because applicant amended claims 1 and 3.
Modified 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.
Claims 1, 3-15, 17-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for administering a composition comprising isolated mesenchymal stem cells (MSCS) to a subject in an amount effective for decreasing a concentration of soluble Tie2 does not reasonably provide enablement for treating aging frailty. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, the enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention:
The instant application is drawn to a method for treating aging frailty in a subject by administering a composition comprising mesenchymal stem cells (MSCs).
(2) the breadth of the claims:
The claims are drawn to treating aging frailty with a dose of MSCs in an amount effective for decreasing the concentration of soluble Tie2 (sTie2) in a subject.
The broadest reasonable interpretation of the ‘aging frailty’ was derived from the specification. The specification describes aging frailty as a geriatric syndrome characterized by weakness, low physical activity, slowed motor function, exhaustion, unintentional weight loss as well as chronic inflammation, immune dysregulation and immunosenescence (skewed T cell and B cell repertoire resulting in less efficient immune status), leading to decreased effectiveness of vaccines (background, page 1).
The detailed description (page 7) of the invention asserts that the symptoms of aging frailty described above can be treated with MSCs by either improving endothelial cell function, promoting the expression of anti-inflammatory cytokines or cellular pathways, simulating intrinsic regenerative or repair pathways in neighboring somatic cells or stem cells, improving the function of immune system and mitochondria in neighboring somatic cells, promoting anti-fibrotic pathways or combinations thereof.
Thus, the independent claim taken together with the specification suggests that the symptoms of aging frailty i.e. weakness, low physical activity, slowed motor function, exhaustion and unintentional weight loss as well as chronic inflammation, immune dysregulation and immunosenescence can be treated with MSC. Also, the treatment should be accompanied by either improving endothelial cell function, promoting the expression of anti-inflammatory cytokines or cellular pathways, simulating intrinsic regenerative or repair pathways in neighboring somatic cells or stem cells, improving the function of immune system and mitochondria in neighboring somatic cells, promoting anti-fibrotic pathways or combinations thereof.
(3) The state of the prior art:
The state of prior art in treating aging frailty with MSCs has reached clinical trial stage. Schulman et al., 2018 teaches a method of administering a therapeutically effective dose of bone-marrow derived, allogenic mesenchymal stem cells (allo-MSCs) to treat aging frailty which resulted in reduction of proinflammatory cytokines including TNF- α, IL-6, IL-β and CRP. They also report improvements in physical performance in patients with aging frailty, measured with parameters 6- min walk distance, and pulmonary function. Tompkins et al., 2017 also teaches intravenous administration of MSCs to treat aging frailty. They investigated changes in physical performance, patient-reported outcomes, and immune markers of frailty measured at six months post treatment. Their results show improvements in six-minute walk test, short physical performance battery test score and forced expiratory volume after 1 second, and reduction in proinflammatory cytokines including TNF- α, as well as a reduction in CD4/CD8 ratio which indicates a significant improvement in the immune risk phenotype.
(4) The predictability or unpredictability of art:
The prior arts Schulman et al., 2018 and Tompkins et al., 2017 predicts the recited changes in biomarkers, functional mobility and/or exercise tolerance and activities of daily living after the MSC treatment (Schulman et al., 2018, table 1, page 4, results of phase I and II clinical trials of MSC for frailty, paragraph 1, page 6 and Tompkins et al., 2017, abstract, page 1513). However, it is unclear if the said changes in biomarkers and functional mobility could successfully treat aging frailty as set forth in the specification.
Therefore, it is unpredictable if the prior art is enabling the scope of the claimed invention to treat aging frailty.
(5) The relative skill of those in the art:
The relative skill of those in the art is high, requiring a graduate degree.
(6) The amount of directions or guidance presented:
Instant specification lacks guidance in how the administration of MSC treat the symptoms of aging frailty in its entirety as mentioned in the background section. i.e. weakness, low physical activity, slowed motor function, exhaustion and unintentional weight loss as well as chronic inflammation, immune dysregulation and immunosenescence.
Also, the specification does not provide guidance to establish if the MSC treatment is accompanied by improving endothelial cell function, promoting the expression of anti-inflammatory cytokines or cellular pathways, simulating intrinsic regenerative or repair pathways in neighboring somatic cells or stem cells, improving the function of immune system and mitochondria in neighboring somatic cells, promoting anti-fibrotic pathways or combinations thereof.
The independent claim is broad and does not recite reasonable limitations to establish what symptoms of aging frailty are treated with the claimed method. At best, the guidance presented teaches a reduction in sTie2 when MSCs are administered to a subject suffering from aging frailty. However there does not appear to be a correlation between reducing sTie2 and treating a symptom of aging frailty.
In other words, it is not clear what symptoms are treated by the decreased sTie2 in a subject. Thus, the scope of the claimed invention set forth by the claims and the specification is not enabled.
Also, the claims of the instant application read on any route of administration of MSC, however the specification has provided guidance for intravenous administration of lomecel-B cells, it’s not clear if the intended route of administration of MSCs is the same.
Therefore, the claims and specification lack guidance that may enable any person skilled in the art to utilize the invention commensurate in scope with these claims.
(7) the presence or absence of working examples:
Instant application lacks working examples to support the broader scope of the claimed invention.
Instant application provides working examples of physical performance assessments such as hand grip strength, short physical performance battery test, forced expiratory volume-1 second test, 4-meter gait speed test and 6-minute walking distance test. However, the specification has not provided a correlation between improvements of these test scores to treatment of any symptoms of aging frailty i.e; weakness, exhaustion and unintentional weight loss etc.
Also, the instant application produces working examples changes in biomarker concentrations such as reduction in TGF-β (pro-inflammatory cytokine), VEGF and soluble Tie2, post MSC treatment (figs. 5 and 6, example 1, pages 13-14). However, the specification has not provided a correlation between the observed changes in the said biomarkers and the symptoms of aging frailty to establish a treatment. Specification recites a correlation between the decreasing sTie2 to increasing 6-minute walking distance test. However, the 6-minutes walking distance test is not a symptom of aging frailty, rather it is a test to assess aging frailty. Further, a reduction in sTie2 does not appear to correlate to treating a symptom of aging frailty. Therefore, it is not clear what symptoms of aging frailty are treated by the method. Similarly, a change in concentrations of TGF-β and VEGF alone do not establish a correlation to reduction of symptoms of aging frailty.
In addition, the instant application does not provide any working examples correlating the symptoms of aging frailty with expression of anti-inflammatory cytokines.
Therefore, the Instant application lacks working examples to enable the scope of the claimed invention.
(8) The quantity of experimentation necessary:
As discussed above, the state of the art is unpredictable over the capability of the recited changes in biomarkers and functional mobility scores to establish treatment for aging frailty as set forth in the specification. Also, the specification lacks guidance implicit or explicit of effective treatment to improve the symptoms aging frailty. Therefore, one of ordinary skill in the art would be burdened with undue experimentation to make and use the claimed invention within the broad scope as instantly claimed. For example, an ordinary artisan will be burdened with establishing a correlation between reducing sTie2 to treating symptoms of aging frailty, thereby an undue quantity of experiments may be needed to determine the aforementioned correlation.
For example, one of ordinary skill in art would be required to perform additional experiments to investigate if the MSC administration can treat symptoms such as weakness, low physical activity, slowed motor function, exhaustion, unintentional weight loss chronic inflammation, immune dysregulation and immunosenescence.
Therefore, the specification, while being enabling for administering a composition comprising isolated MSCs to a subject in an amount effective for decreasing a concentration of soluble Tie2 does not reasonably provide enablement for treating aging frailty.
New Claim Rejections - 35 USC § 112(b)
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.
Regarding claim 15, this claim is dependent on claim 3 and 13, claim 3 recites ‘the method of claim 1, further comprising determining concentration of a biomarker in the subject suffering from symptoms of aging frailty’. However, the instant claim recites the method of treatment further comprising increasing concentration of the anti-inflammatory cytokine. There appears to be a missing step in the instant claim, because claim 1 requires administering MSCs that results in decreasing sTie2 and claim 3 requires determining a concentration of a biomarker while the language of claim 15 is an active step of “increasing concentration of the anti-inflammatory cytokine”. It is not clear if an additional step is required or if increasing concentration of the said anti-inflammatory cytokine is a result of administration of MSCs. Therefore, the claim is indefinite.
Regarding claim 17, this claim is dependent on claim 1 which recites the administration of MSCs in an amount effective for decreasing a concentration of soluble Tie2 (sTie2) in a subject, wherein ‘decreasing a concentration of sTie2’ appears to be an intended result of the claimed treatment method. However, claim 17 recites an active step, the method of claim 1, further comprising decreasing the concentration of the sTie2’. It is not clear how the passive language of claim 1 corelates to the active language of claim 17, and if an additional step is required or if decreasing sTie2 is a result of administration of MSCs. Suggested language is as follows ‘The method of claim 1, wherein the concentration of sTie2 is decreased by…..’.
Regarding claim 19, this claim is dependent on claim 1 which recites the administration of MSCs in an amount effective for decreasing a concentration of soluble Tie2 (sTie2) in a subject, wherein ‘decreasing a concentration of sTie2’ appear to be an intended result of the claimed treatment method. However, claim 19 recites an active step, the method according to claim 18, further comprising increasing concentration of the Tie 2’. It is not clear how the passive language of claim 1 corelates to the active language of claim 19. Specification is silent about how the decrease in sTie2 results in an increase of Tie2. It is not clear if an additional step is required or if increase in Tie2 is a result of administration of MSCs. Suggested language is as follows ‘The method of claim 18, wherein the concentration of Tie2 is increased’.
Regarding claim 21, this claim is dependent on claim 3 and 20, claim 3 recites ‘the method of claim 1, further comprising determining concentration of a biomarker in the subject suffering from symptoms of aging frailty’. However, the instant claim recites; the method of treatment further comprising increasing concentration of the VEGF. There appears to be a missing step in the instant claim, because claim 1 requires administering MSCs that results in decreasing sTie2 and claim 3 requires determining a concentration of a biomarker while the language of claim 21 is an active step of “increasing a concentration of the VEGF”. It is not clear if an additional step is required, or if the increase in VEGF is a result of administration of MSCs. Therefore, the claim is indefinite for missing an essential step.
Regarding claim 22, the term “stable” in claim 22 is a relative term which renders the claim indefinite. The term “stable” in the phrase “stable concentration” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Since the “stable concentration” is not defined, it is not clear how to determine if the implied concentration is reached. Therefore, all the limitations/steps of the instant claim are indefinite.
Modified Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 4-9 are rejected under U.S.C. 101 because the claimed invention is directed to a judicial exception (abstract idea in accordance to MPEP 2106.04 (a)) without significantly more. This judicial exception is not integrated into a practical application, and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
Step 1 (Statutory Category): This part of the eligibility analysis evaluates whether the claim falls within any statutory category. Claims 4-9 are dependent on claim 1 which recites a method of treating aging frailty with bone-marrow derived MSCs which is a process. Therefore, the claims fall within a statutory category.
Step 2A (Judicial Exceptions), Prong 1: This part of the eligibility analysis evaluates whether the claim recites a judicial exception i.e. abstract idea.
MPEP 2106.04 (a) states the following:
To facilitate examination, the Office has set forth an approach to identifying abstract ideas that distill the relevant case law into enumerated groupings of abstract ideas.
The enumerated groupings of abstract ideas are defined as:
1) Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations (see MPEP § 2106.04(a)(2), subsection I);
2) Certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) (see MPEP § 2106.04(a)(2), subsection II); and
3) Mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III).
Claims 4-9 are subjected to the judicial exception; abstract idea in accordance to MPEP 2106.04 (a) for reciting a mental process for the reasons set forth below.
Regarding claim 4, the claim is drawn to determining subject’s functional mobility or exercise tolerance. The recited steps appear to involve a mental process of observing a subject’s mobility.
Regarding claim 5 the claim is drawn to determining the subject’s ability to perform activities of daily living. The recited steps appear to involve a mental process of observing a subject performing activities of daily living.
Regarding claim 6, the claim is drawn to examining the subject's PROMIS Physical Function score. The recited steps appear to involve a mental process of looking at PROMIS score.
Regarding claim 7, the claim is drawn to determining the subject's PROMIS Mobility score. The recited steps appear to mathematically calculate PROMIS score.
Regarding claim 8, the claim is drawn to determining subject’s handgrip strength. The recited steps appear to involve a mental process of observing a subject gripping an object.
Regarding claim 9, the claim is drawn to determining subject’s gait or balance. The recited steps appear to involve a mental process of observing a subject’s gait or balance.
Thus, the claims recite a judicial exception, an abstract idea. Therefore, the analysis proceeds to step 2A prong 2.
Step 2A (Judicial Exceptions), Prong 2: This part of the eligibility analysis evaluates whether the claims as a whole integrate the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claims beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claims as a whole integrate the exception into a practical application.
Claims 4-9 do not recite additional elements. Tompkins, et al., Journals of Gerontology Series A: Biomedical Sciences and Medical Sciences 72.11 (2017): 1513-1522, teaches administration of MSC in an effective amount (abstract, page 1513) which anticipates at least claim 1 on which the claims 4-9 depend.
Step 2B (Significantly More): This part of the eligibility analysis evaluates whether the claims as a whole amount to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP 2106.05). This is based on an additional consideration of whether the elements in addition to the judicial exception add beyond what was well-understood, routine, and conventional to the claims.
The are no additional elements in claims 4-9 that contribute over prior art or intended uses or add any inventive concept in addition to the exception beyond what was well-understood, routine, and conventional. Therefore, the claims as a whole fail to amount to significantly more than the exception recited.
New Claim Rejections - 35 USC § 102 as Necessitated by Amendment
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 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.
Claims 1, 3-5, 10, 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tompkins, et al., Journals of Gerontology Series A: Biomedical Sciences and Medical Sciences 72.11 (2017): 1513-1522.
Regarding claim 1, Tompkins teaches a method for treating the symptoms of aging frailty by administering a therapeutically effective dose of human allogenic mesenchymal stem cells (allo-hMSCs). Tompkins established the method of treatment by completing a randomized, double-blinded, placebo-controlled study and found that intravenous administration of 100 million – 200 million cells to be therapeutically effective (abstract, page 1513). Decreasing concentration of sTie2 is the intended result of the claimed treatment method. Tompkins teaches an effective amount of MSCs to treat a subject suffering from aging frailty. Therefore, Tompkins teaches the requisite limitations.
Regarding claim 3, Tompkins determined concentration of biomarkers after the MSC treatment (abstract, page 1513, fig.3, page 1519). They observed decreased serum TNF- α levels in 100 million dose group, after the treatment (abstract, page 1513, fig.3, page 1519).
Regarding claim 4, Tompkins teaches improvements in functional mobility/ exercise tolerance indicated by the improved physical performance in patients with aging frailty, including 6-min walk distance, and short physical performance exam after the allo-hMSC treatment (abstract, page 1513).
Regarding claim 5, Tompkins teaches improvements in 6- min walk distance, improvements in female sexual quality of life, increase in physical performance and forced expiratory volume in 1 second (abstract, page 1513), all of which read on improved ability to perform activities of daily living.
Regarding claim 10 and 11, Tompkins teaches a change in concentration of proinflammatory cytokine after administration of allo-hMSCs, where proinflammatory cytokines include TNF- α, (abstract, page 1513, fig.3, page 1519).
Therefore, the reference anticipates the claimed subject matter.
Response to Arguments
Applicants’ arguments submitted on the responsive filed on 06/11/2026 were fully considered. While some arguments along with claim amendments led to withdrawal of rejections others were modified.
35 U.S.C. 101 rejection on claim 3 was withdrawn based on the claim amendments. However, claims 4-9 recite abstract ideas even after the amendments as discussed in the 35 U.S.C. 101 rejection on the final action.
Applicant argues that, since claim 1 is not directed at a judicial exception, all the other claims depend on claim 1, also include all the limitations of claim 1 which is significantly more than abstract idea.
Examiner points out that Tompkins teaches administering an effective amount of MSC to a subject suffering from aging frailty (abstract, page 1513), and the claim 1 does not specify the required amount and reads on any amount of MSCs for the treatment of aging frailty. The limitation, decreasing concentration of sTie2, as currently stated is an intended result of the claimed method. Therefore, the requisite limitations of the claim 1 were known and routine in the art and do not add significantly more than the judicial exception. Hence the 35 U.S.C, 101 rejection on claims 4-9 was modified and maintained
Applicant argues that decreasing concentration of sTIe2 as recited is an effective means for preserving the structural integrity and biological function of microvascular endothelium and that the pending claims do not recite a method of alleviating the symptoms of aging frailty. Therefore, the examiner’s arguments for lack of enablement are not relevant to the pending claims
In response, it is pointed out that the pending claims are in fact directed to methods of treating a subject suffering from aging frailty. It is not understood how treating aging frailty would not result in alleviating a symptom of aging frailty.
Moreover, the claims don’t recite preserving the structural integrity and biological function of microvascular endothelium.
Further the aging frailty is characterized by a broader range of symptoms such as weakness, low physical activity, slowed motor function, exhaustion and unintentional weight loss as well as chronic inflammation, immune dysregulation and immunosenescence (specification, page 1). Also, the specification recites that MSC treatment alleviates the symptoms of aging frailty by either improving endothelial cell function, promoting the expression of anti-inflammatory cytokines or cellular pathways, simulating intrinsic regenerative or repair pathways in neighboring somatic cells or stem cells, improving the function of immune system and mitochondria in neighboring somatic cells, promoting anti-fibrotic pathways or combinations thereof (page 7, last paragraph) .
Applicant further argues that there is a clear correlation between a reduction in the concentration of sTie2 and an improvement in the symptoms of aging frailty based on 6-minute walk test (6MWT), pointing to the drawing 5C.
In response, Examiner points out that 6MWT is neither a limitation of claim 1, and nor a symptom of aging frailty. It is not clear how the decrease in sTie2 correlates to alleviation/treatment of symptoms of aging frailty. Applicant is encouraged to point out which symptom of aging frailty was treated.
Applicant argues that the 35 U.S.C. 102 rejection on the non-final action should be withdrawn based on the amendments to claim 1.
In response, the Examiner modified the 35 U.S.C 102 rejection to include prior art Tompkins et al., 2017 based on the claim amendments. Similarly to Schulman, Tompkins also teaches administering a therapeutically effective dose of MSC to treat aging frailty. The added limitation ‘for decreasing a concentration of sTie2’ is an intended result from administering an effective amount MSCs. The claims do not specify what the effective amount is, as such it reads on any amount. Applicant is invited to provide evidence as to why the effective amount of MSCs administered by Tompkins would not decrease the concentration of sTIE2. Therefore, the requisite limitations of the claims 1, 3-5, 10 and 11 are anticipated by Tompkins.
Conclusion
No claim is allowed
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/HASHANTHI KOMITIGE ABEYRATNE-PERERA/ Examiner, Art Unit 1632
/PETER PARAS JR/ Supervisory Patent Examiner, Art Unit 1632
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