DETAILED ACTION
This office action is in response to applicant’s filing dated May 5, 2026.
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 Claims
Claims 55 – 82 are pending in the instant application. Claims 56, 65, 67, 70-71 and 74 remain withdrawn, as being drawn to an unelected invention or specie.
Claims 55, 57-64, 66, 68, 69, 72, 73 and 75-82 are under examination in the present office action.
Objections and/or Rejections and Response to Arguments
Acknowledgement is made of the Applicant’s argument regarding objection of claim 76, as shown herein: “[…]claim 75 recites the compound or a pharmaceutically acceptable salt thereof whereas claim 76 recites only the compound”. The argument is persuasive.
Accordingly objection of claim 76 is withdrawn.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Maintained Objections and/or Rejections
Claim Rejections - 35 USC § 112(a)
Scope of enablement
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 55, 57-64, 66, 68, 69, 72, 73 and 75-82 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 treatment of breast cancer related inflammation with compounds recited in Table 7 (specification, pages 233 – 236), does not reasonably provide enablement for treating full scope of diseases (all auto-immune diseases, neurodegenerative diseases and viral infection) with full scope of compounds of genus Formula (I), encompassed by instant claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in /n re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
Nature of the invention and the Breadth of the claims.
The invention is drawn to a method of treatment of any inflammatory disease, viral infection, any auto-immune disease and any neurodegenerative disease with all the compounds of Formula (I)
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. The breadth of the claims is extensive.
Scope of the compound covered:
The number of compounds encompassed by the formula above is also vast since the formula encompasses a large number of possible structural components for each variable of the compound of formula (I) and as such combinations of the various variables recited in the claims would yield millions of compounds.
The formula contains 4 different R groups combinations plus variety of structures of ring A and element L1. Each of these variables are defined to be any one of the many different moieties, for e.g.:
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. These compounds encompass molecules that widely vary in the physical and chemical properties such as size, molecular weight, acidity, basicity, and properties that are known in the art to greatly influence pharmacokinetic and pharmacodynamics parameters, not to mention the ability to productively bind to claimed biological target molecules. The claims cover compounds easily in the millions given the number of possible rings, ring systems covered by the claims' scope along with varying choices for remaining variables. Each of these compounds is claimed to be useful in the method of treating all inflammatory diseases, auto-immune diseases, neurodegenerative diseases and any viral infection.
Scope of the diseases covered:
There are numerous autoimmune and inflammatory diseases, some of these diseases are hereditary and genetic and untreatable. Furthermore, applicants claim the method of treating all viral infections, which include e.g.:
- upper respiratory infections include sore throat, sinusitis, and the common cold. Other viral respiratory infections include influenza, pneumonia, and coronaviruses, including SARS-CoV-2 (the virus that causes COVID-19);
- gastrointestinal tract: Infections of the gastrointestinal tract, such as gastroenteritis, are commonly caused by viruses, such as noroviruses and rotaviruses;
- liver: These infections result in hepatitis;
- nervous system: some viruses, such as the rabies virus and the West Nile virus, infect the brain, causing encephalitis. Others infect the layers of tissue that cover the brain and spinal cord (meninges), causing meningitis. This is not an exhaustive list of diseases, caused by virus.
Moreover, applicant proposes to treat all neurodegenerative diseases. All named above conditions applicant proposes to treat with all the compounds of Formula (I), where compounds act as CDK 4/6 inhibitors.
2. Relative skill of those in the art.
The level of ordinary skill in the art may be found by inquiring into: (1) the type of problems encountered in the art; (2) prior art solutions to those problems; (3) the rapidity with which innovations are made; (4) the sophistication of the technology; and (5) the education level of active workers in the field. Custom Accessories, Inc., 807 F.2d at 962. All of those factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed.Cir.1983).
Based on the typical education level of active workers in the fields of Medicinal chemistry, biology, biochemistry, and pharmacology, as well as the high degree of sophistication required to solve problems encountered in the art, the Examiner finds that a person of ordinary skill in the art would have at least a college degree in one of the fields identified above and at least four years of work experience; i.e. a masters or doctorate level scientist.
3. The predictability or unpredictability of the art and the state of the prior art.
The instantly claimed invention is highly unpredictable as discussed below:
It is noted, that the various diseases and disorders have different causes and molecular mechanisms which contribute to the final pathology and clinical manifestations of the disease. There is no common mechanism by which all auto-immune diseases, neurodegenerative disease and viral diseases arise. Accordingly, treatments for these diseases are normally tailored to the particular type of disease as there is no, and there can be no “magic bullet” against e.g. viral infections or disorders in general. The pathogenesis of these diseases is complex and different.
Accordingly, the unpredictability of treating any of the mentioned above diseases with the CDK inhibitors is very high. It is well established that “the scope of enablement varies with the degree of unpredictability of the factors involved” and physiological activity is considered to be an unpredictable factor. See In re Fisher, 166 USPQ 18, at 24 (In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved); Nationwide Chemical Corporation, et. al. v. Wright, et. al., 192 USPQ 95 (one skilled in chemical and biological arts cannot always reasonably predict how different chemical compounds and elements might behave under varying circumstances); In re Wright 27 USPQ2d 1510 (the physiological activity of RNA viruses was sufficiently unpredictable that success in developing specific avian vaccine was uncertain). As illustrative of the state of the art, the examiner cites: Yan et al (J Med Virol. 2022;94:2962–2968.), Zhang et al (Am J Clin Exp Urol 2021;9(1):32-43) and Gopukumar et al (Preprints 2025, 2025091889. https://doi.org/10.20944/preprints202509.1889.v1).
With regards to unpredictability, Yan et al., cited for evidentiary purposes teaches: recent studies have demonstrated the critical roles of CDKs in various viral infections. However, the molecular processes underpinning CDKs' roles in viral infection and host antiviral defense are unknown (abstract). CDK activity suggests that CDKs function regulation might be potential therapeutic targets against e.g. HIV‐1 infection. However, the underlying mechanisms by which CDKs regulate the HIV replication cycle appear complicated. More studies are needed to determine whether HIV uses one or more CDKs and coordinates the network to promote HIV infection (page 2964, left column, 3rd and 4th paragraph).
With regards to unpredictability, Zhang et al., cited for evidentiary purposes teaches effect of CDK4/6 inhibitor palbociclib on treatment of an autoimmune inflammatory disease Lupus. CDK4/6 inhibitor palbociclib was introduced to lupus-prone MRL-lpr mouse model, and was able to reduce inflammation in the facial skin and lymph nodes, two main clini-cal features of lupus in the female mice. However, palbociclib treatment did not inhibit the spleen enlargement. Palbociclib treatment was only able to inhibit nephritis in the male mice, but not the female mice. These findings suggest that palbociclib has certain gender-/organ-specific actions, the underlying mechanisms of which are unknown. In human patients who receive palbociclib treat-ment, about 1-3% develop life-threatening interstitial lung disease and/or pneumonitis.
Therefore, it remains unclear how palbociclib inhibits the inflammation and further studies are needed to determine the mechanisms of action (page 41, left and right columns).
With regards to unpredictability, Gopukumar et al., cited for evidentiary purposes teaches: Immunomodulators targeting tumor-associated inflammation may be adapted to dampen chronic microglial activation in the AD brain. Experimental dampening of CDK activity reduces Aß toxicity and preserves cognition in transgenic (AD) models. Translational caveats include dose, schedule, and brain exposure; peripheral anti-proliferative effects must be minimized while achieving CNS target engagement (page 4, paragraph 2.1.). Gopukumar et al., point out following pitfalls:
Dose re-engineering: Oncology paradigms aim for maximum tolerated dose and short courses; AD requires chronic, lower-intensity modulation in elderly patients.
BBB and delivery: Brain exposure is a recurrent bottleneck. Strategies include medicinal chemistry (lipophilicity, P-gp avoidance), alternative routes (intranasal, intrathecal), and device-assisted delivery (focused ultrasound). Each introduces operational and safety complexity that must be justified by robust pharmacodynamic markers.
CNS off-targets: Multikinase profiles and epigenetic breadth can perturb protective signaling or synaptic programs; rigorous neurobehavioral monitoring and phased dose-finding are essential (page 15, paragraph 5.2.).
These articles plainly demonstrate that the art of developing and testing therapies to treat any and all types of diseases with all the compounds encompassed by instant claims is unpredictable. More generally, the invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
4. Amount of guidance/existence of working examples.
The instant claims, directed to a method of treating all inflammatory, auto-immune, neurodegenerative diseases and viral infection with full scope of compounds of genus Formula (I) are extremely broad in contrast with the specification that only provides data, showing therapeutic activity of 131 compounds, encompassed by Formula (I) (Table 7) on MCF7 cell line. Although specification provides general direction or guidance of:
- formulation, e.g.: “The subject pharmaceutical compositions can be administered alone or in combination with one or more other agents[…]” or “the concentration of one or more compounds provided in the pharmaceutical compositions of the present invention is less than 100%, […] or 0.0001 % (or a number in the range defined by and including any two numbers above) w/w, w/v or v/v” (page 70 – 71, [00311] and [00312];
- dosages, e.g.: “The compounds according to the invention are effective over a wide dosage range. For example, in the treatment of adult humans, dosages from 0.01 to 1000 mg […] per day” (page 72, [00319]);
and
- administration routes, such as oral, injection, transdermal or inhalation (pages 73 – 83), necessary to treat all of the various diseases encompassed by the claims, the directions are very broad and include vast variety of known formulations.
While experimentation is presented for treatment of breast cancer, there is no experimentation or mechanism of action presented or discussed in the specification regarding treatment of the conditions that are not breast cancer. Absence of working examples is a critical factor to be considered, especially in a case involving an unpredictable and undeveloped art. See MPEP 2164.
5. The quantity of experimentation necessary.
Because of the known unpredictability of the art (as discussed supra) and in the absence of experimental evidence commensurate in scope with the claims, the skilled artisan would not accept that all the compounds of general Formula (I), except those listed in Table 7, which are useful in the treatment of breast cancer or inflammation associated with breast cancer, could be predictably used as treatment for all inflammatory, autoimmune, neurodegenerative diseases and viral infection. Genentech Inc. vs. Nova Nordisk states, "[A] patent is not a hunting license. It is not a reward for a search but a compensation for its successful conclusion and ‘patent protection’ is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable" (42 USPQ 2d 1001, Fed. Circuit 1997). As noted above, none of the experimentation provided is drawn to the treatment of all inflammatory, autoimmune, neurodegenerative diseases and viral infection, except for the treatment of inflammation, related to breast cancer. A review of the state of the art fails to reveal that all the compounds encompassed by formula (I) in combination with additional therapeutic agent are useful as a therapeutic for the treatment of all inflammatory, autoimmune, neurodegenerative diseases and viral infection, except for the treatment of inflammation, related to breast cancer. Determining if any particular claimed compound would treat any particular disease state, would require synthesis of the compound, formulation into a suitable dosage form, and subjecting it to clinical trials or to testing in an assay known to correlate to clinical efficacy of such treatment. This is undue experimentation given the limited guidance and direction provided by Applicants. As noted supra, even in vitro and in vivo assays do not always correlate to efficacy in humans and are not generally predictive of clinical efficacy.
Accordingly, the instant claims do not comply with the enablement requirement of 35 U.S.C. 112(a), since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Response to Arguments
Applicant argues:
- Applicant submits that claims are enabled as filed, since CDK4 and CDK6 inhibitors are known in the art to treat the claimed conditions (i.e., auto-immune diseases, neurodegenerative diseases and viral infections).
- Applicant further lists several references teaching CDK4/6 inhibitors such as abemaciclib, palbociclib, or ribociclib are effective in treating some auto-immune diseases, Kaposi sarcoma-associated herpesvirus (KSHV) and Epstein-Barr virus (EBV), as well as have certain positive outcomes in treatment of AD.
Examiner’s response:
Applicant's arguments have been fully considered but they are not persuasive because: as set forth above, the number and variety of compounds encompassed by the Formula (I) is vast and far exceeds the more limited subset of structures, evaluated in the experimental examples. These compounds encompass molecules that widely vary in the physical, chemical and biological properties. MPEP 2164.02 states: “For a claimed genus, representative examples together with a statement applicable to the genus as a whole will ordinarily be sufficient if one skilled in the art (in view of level of skill, state of the art and the information in the specification) would expect the claimed genus could be used in that manner without undue experimentation”. In the instant case the genus is very broad and encompasses compounds that vary widely in structure. Thus, a person skilled in the art could not use the genus as a whole without undue experimentation.
Regarding variety of diseases and conditions to be treated, the experimentation is presented for treatment of breast cancer, there is no experimentation presented or discussed in the specification regarding treatment of the conditions that are not breast cancer. Absence of working examples is a critical factor to be considered, especially in a case involving an unpredictable and undeveloped art. See MPEP 2164. The presented data do not provide enough evidence to enable treatment of all the claimed conditions with all compounds encompassed by genus Formula (I).
Regarding argument about effectiveness of CDK4/6 inhibitors in treating all the claimed diseases or conditions, it is not persuasive because, although CDK4/6 inhibitors share the same primary mechanism of action (inhibit cyclin-dependent kinase 4 and 6) and potentially might be effective in treatment of specific inflammatory conditions (e.g. lupus or rheumatoid arthritis), any extrapolation of their efficacy to generalized inflammatory conditions if not supported. For example, treatment of acute and chronic inflammation require a different approach, moreover treatment of acute inflammation with CDK4/6 inhibitors can be dangerous.
The skilled artisan would not accept that any drug acting as CDK4/6 inhibitor would be equally effective in treatment for any inflammatory, autoimmune, neurodegenerative diseases and viral infection. Different agents of this class of drugs have a different chemical structure and thus, distinct properties. To support this statement Examiner cites Braal et al (Drugs 81, 317–331 (2021)). Braal teaches palbociclib, ribociclib, and abemaciclib, belonging to the same class of drugs, (CDK) 4/6 inhibitors, and their similarities and distinctions, such as pharmacokinetic profiles, toxicity and efficacy in treatment of breast cancer. According to Braal’s studies “a distinguishing feature of abemaciclib in comparison with the other CDK4/6 inhibitors is its ability to penetrate breast tissue and the blood–brain barrier more efficiently due to its higher lipophilicity. The hypothesis was confirmed by preclinical data from abemaciclib in human xenograft models, which showed decreased tumor growth in the brain, and when compared with palbociclib and ribociclib, abemaciclib had the highest unbound brain-to-plasma ratio, suggesting effective penetration” (page 320, “Distribution”). Braal further teaches that palbociclib, ribociclib, and abemaciclib display subtle differences in kinase selectivity. Abemaciclib is the most potent CDK4/6 inhibitor and is approximately five times more potent against CDK4 than CDK6 (pages 320-321 “Pharmacodynamics”). The main side effects of CDK4/6 inhibitors are bone marrow suppression—such as neutropenia, anemia, and thrombopenia and gastrointestinal toxicities. However, there seem to be some distinct differences between the three drugs. Grade 3–4 neutropenia was the most reported adverse event for palbociclib (66%) and ribociclib (60%) and was the second most reported adverse event in patients treated with abemaciclib (22%) (page 323, “Neutropenia”).
Thus, according to In re Wands factors (see above): the claims are broad in scope; the nature of the invention is sophisticated; the state of the prior art does not establish any drug to treat all claimed conditions; the level of skill is high; the level of unpredictability is high; the direction provided by the inventor is limited to specification; the existence of working examples is limited; and the quantity of experimentation includes testing the claimed composition against every claimed disease or disorder.... Thus, based on the In re Wands factors, the claims lack enablement.
Therefore, Applicant’s arguments are not persuasive and the rejection of claims 55, 57-64, 66, 68, 69, 72, 73 and 75-82 under 35 U.S.C. 112(a) as lacking enablement is maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 55, 57-64, 66, 68, 69, 72, 73, 75, 76 and 78 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 20 and 59 of copending Application No. 18/849,602 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims are directed to a method of treating an auto-immune disease, neurodegeneration, an inflammatory disease or a viral infection in a patient in need thereof, comprising administering to said patient a compound of Formula (I), such as compound of structure
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(example 56) or a pharmaceutically acceptable salt thereof, where said compound acts as CDK4/6 inhibitor.
Copending claims are directed to a compound of formula A:
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, or a pharmaceutically acceptable salt thereof. Copending claims are also directed to a pharmaceutical composition comprising a compound of formula A or a pharmaceutically acceptable salt thereof. The compound of formula A acts as CDK4/6 inhibitor and is useful for treatment of inflammatory breast cancer (page 57, [00317]), autoimmune or inflammatory conditions (page 62, [00338]).
Thus, since copending claims disclose a pharmaceutical composition comprising compound of formula A or its salt, suitable to treat inflammatory breast cancer, and autoimmune or inflammatory conditions, and instant claims disclose the method of treatment autoimmune or inflammatory conditions using the same product, case of obviousness present.
Taken all, it would have been prima facie obvious to one of ordinary skill in the art to arrive at the method of instant claims using the product, disclosed by copending claims, and suitable to treat the same types of conditions, with the reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues:
Applicant asks that this rejection be held in abeyance until an indication of allowable subject matter has been realized in the instant case.
Examiner’s response:
Applicant's arguments have been fully considered but they are not persuasive because: as set forth above, instant claims and copending claims teach structurally identical or similar compounds, useful for the same purpose. According to MPEP 804: If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the rejection in the application having the earlier patent term filing date should be withdrawn.
Since provisional nonstatutory double patenting rejection is not the only rejection in the instant application, the argument is not found persuasive.
Therefore, the provisional rejection of claims 55, 57-64, 66, 68, 69, 72, 73, 75, 76 and 78 on the ground of nonstatutory double patenting over claims of copending Application No. 18/849,602 is maintained.
Conclusion
Claims 55, 57-64, 66, 68, 69, 72, 73 and 75-82 are rejected. 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.
E.V.V./ Examiner, Art Unit 1691
/SAVITHA M RAO/ Primary Examiner, Art Unit 1691
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