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 .
Claim Status
Claims 1,9,19, and 21 are amended.
Claims 4,18, and 27-29 are cancelled.
Claims 1-3,5-17, and 19- 26 are under examination.
Withdrawn Rejections
The rejections of claims 9 and 21 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of Applicants amendment.
Edited Rejections necessitated by Claims Amendment
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 9 and 21 are 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.
Claims 9 and 21 require culturing cancer cells in a medium containing a growth factor to increase the expression level of a specific marker in the cells prior to the coculturing step.
Upon reviewing the specification, in view of the presented claims, the specification shows that Applicants have not provided sufficient description of all the growth factors that would be used to induce the expression level of specific markers. The specification does not even provide sufficient description of which growth factor to be used to induce which marker. The specification states that “ The cancer cells are grown in the presence of known growth factor as supplements ( e.g., epidermal growth factor, insulin, or insulin-like-growth factor, depending upon the cell-type) which are known to induce the expression level of the markers” but does not specify which markers would be induced by using the exemplified growth factors or the candidate cancer cell types. The specification also does not provide sufficient information of the type of cancer cells that would be used in such a system to produce predictable results. Possession of an invention may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998).
The claim recites the structure (e.g. growing cancer cells in a medium containing a growth factor) has function (e.g. induce the expression level of a specific marker). There is no data to show which growth factor should be utilized on which cancer cell type to induce the expression of what marker. The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed. It is apparent that applicants do NOT have possession of growing any cancer cell type in a medium containing any growth factor that would induce the expression of any marker. Consequently, the claims are considered to lack sufficient written description and are properly rejected under 35 USC 112, first paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3,5-17, and 19- 26 are rejected under 35 U.S.C. 103 as being unpatentable over Imam et al ( US 2018/0275027 A1), in view of Kastner et al ( Molecular Cancer Research, 2012), Meijden et al ( Cancer Research, 2002), Santo et al ( Journal of Biotechnology, 2016), Gabriel et al ( Scientific Reports, 2019), and Cui et al (Cancer Research, 2006), as evidenced by Simon et al ( Bio techniques, 2016) .
Regarding claim 1, Imam et al disclose a method for making synthetic tissue controls (STC) and synthetic tissue microarray controls (STMC) for immunohistochemical (IHC) and in situ hybridization (ISH) testing for cancer diagnosis and prognosis. Imam et al also provide methods for determining presence of one or more types of cancer. (Paragraph [0003]). Imam et al disclose that STMC is constructed to include a plurality of types of cancer cells with varying levels and patterns of expression of markers of interest, this reads on selecting cancer cells with a known positivity or negativity for a specific marker. (Paragraph [0042]). Imam et al also teach that the method of constructing the STC and STMC involves coculturing cancer cells and stromal cells in a plurality of cell culture bags, with the cell culture bag being mounted on a bioreactor in a CO2-incubator during the co-culturing process (Paragraphs [0005], [0030]), this reads on steps 4-5 of instant claim. According to Imam et al, the coculturing process is held in an approximately zero gravity environment for a period of eight to twelve days (Paragraphs [0031). Imam et al also teach utilizing a motorized rotating device to slowly spin the cell culture chambers at a speed to allow the cells to develop characteristics similar to or identical to characteristics of actual tumor tissue (Paragraphs [0031). Imam et al further teach harvesting, fixing, and embedding the fixed cocultured cells in a paraffin block core. ( See Paragraphs [0027], [0038], and Fig.1, and Fig.2D-wherein the 204 represent the cocultured cells deposited in the core of the block),
Imam et al do not teach growing cancer cells to a phase (i.e. the second step); nor do they teach screening the cancer cells in the phase for expression of a specific marker (i.e. the third step).
Kastner et al supplement Imam et al by teaching that the mRNA encoding orphan G protein-coupled receptor 19 (GPR19) is frequently overexpressed in tissue samples obtained from patients with small cell lung cancer (SCLC) (See abstract, and Fig.1). Kastner et al further demonstrate that the expression levels of Gpr19 mRNA varied along the cell-cycle with a peak observed in S-phase (See abstract, and Fig.6). In other words, Kastner et al supplement Imam et al by teaching that specific markers such as Gpr19 is temporally associated with specific stages of cell cycle. As such, an ordinary skill in the art would be motivated to grow cancer cells to a specific cell cycle phase prior to their use in IHC to obtain cell populations exhibiting elevated expression of corresponding specific markers.
Another prior art by Meijden et al further supplement Imam et al for teaching that the expression of particular biomarkers is temporally associated with specific stages of the cell cycle and that synchronized cancer cell exhibits predictable phase-dependent marker expression. ( See abstract). It should be noted that cell synchronization reads on growing cell to a phase. Specifically, Meijden et al teach that specific markers exhibit predictable increase in expression at defined stages of the cell cycle.( See Fig.3). For example, by synchronizing cultured cancer cells and collecting cells during late S phase or G-2/M phase, Meijden et al show that genes such as cyclin B, polo-like kinase (PLK), and cdc20-related gene ( p55CDC) are preferentially expressed during G2/M phase, while cyclin A, Hep27, and EPR-1 are preferentially expressed in late S phase. ( See Figs.2B and 3). Therefore, in view of Kastner and Meijden et al teachings it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention was filed to modify the teachings of Imam et al and synchronize cancer cell to S phase or G2/M phase (i.e. grow cell to a phase) to obtain cell populations exhibiting elevated expression of corresponding phase-associated markers. Because Imam et al disclose a method for making tissue reference control block (i.e. STC and STMC) for IHC and ISH testing by selecting cancer cells with a known positivity or negativity for a specific marker, but fail to teach growing cancer cells to a phase for an expression of the specific marker. Kastner and Meijden et al supplement Imam et al by teaching that specific markers is temporally associated with specific stages of cell cycle, and that synchronized cancer cells (i.e. growing cells to a phase) may exhibit predictable phase-dependent marker expression. Therefore, it would have been obvious to an ordinary skill in the art to enrich a cancer-cell population for a selected cell-cycle phase to obtain elevated expression of a desired marker before fixation or embedding, because Kasner and Meijden et al expressly teach that some markers reach maximal expression at specific stages of S phase or G2/M phase. There is a reasonable expectation of success to grow cancer cells to a specific phase prior to the coculturing step because doing so would provide various cancer cells with different expression level that can be used as a reference control for cancer diagnosis. In other words, steps 2-3 of instant claim would have been obvious to one of ordinary skill in the art, as there was some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Imam et al, on the other hand, do not explicitly teach culturing cells to form spheroids, and hence do not teach harvesting, fixing, or embedding spheroid in a core of paraffin block (i.e. steps 6-8).
Santo et al supplement Imam et al for teaching a method of utilizing a stirred-tank culture strategies for large scale production of multicellular spheroid-based tumor cell model. According to Santo et al, the stirred tank platform supports large-scale and reproducible generation of tumor spheroids suitable for downstream analytical applications including therapeutic evolution and target verification in pre-clinical oncology research. ( See abstract). Santo et al also teach that the system is adaptable to different tumor cell lines and culture conditions. Furthermore, Santo et al demonstrate that the stirred-tank approach is highly adaptable for both homotypic (single cell line) and heterotypic (tumor and stromal cell lines) 3D models. For example, Santo et al demonstrate that stromal cells, such as fibroblasts, alongside tumor cells can be introduced to establish complex, biologically relevant co-cultures. ( See abstract, and sections 2.2. and 2.3.). Santo et al teach further teach utilizing the generated spheroids in phenotypic characterization ( e.g. screening for apoptotic activity) which involves fixation, embedding, and sectioning. (See section 2.5.4.2. on page 120). As such, Santo et al provide an ordinary skill in the art with the motivation to generate large numbers of tumor spheroids comprising of cancer and stromal cells that can be used in the method of Imam et al to prepare tissue reference control block in the IHC and ISH testing .
Furthermore, Gabriel et al supplement Imam by teaching a microarray-based embedding and sectioning platform for parallel histological analysis of multiple 3D cell spheroids. According to Gabriel et al, fixed spheroids, are positioned within a microwell array under aqueous conditions, stabilized in agarose, and paraffin embedded, sectioned, and stained collectively on common histological slides. Gabriel et al state that such system enables simultaneous processing and imaging of up to 96 spheroids, thereby increasing throughput and improving staining consistency between samples. ( See abstract, and Fig.5).
Therefore, in view of Santo and Gabriel et al teachings it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to modify the teachings of Imam et al to coculture mixture of cells to produce spheroid and use them to prepare tissue reference block. Because Imam et al disclose a method for making tissue reference control block (i.e. STC and STMC) for IHC and ISH testing for cancer diagnosis and prognosis by selecting cancer cells with a known positivity or negativity for a specific marker, but fail to teach growing cancer cell to produce spheroids and using them for screening. Santo et al supplement Imam et al by teaching the generation of large numbers of tumor spheroids that are suitable for screening. Gabriel et al teach embedding, arraying, sectioning, and staining multiple spheroids in parallel for biomarker analysis. Therefore, it would have been obvious to an ordinary skill in the art at the time the invention was filed to modify the teachings of Imam by utilizing the method of Santo et al to generate a large scale of spheroids and use them within the tissue reference control block of Imam et al , as taught by Gabriel et al. Because both Santo and Gabriel are directed to three-dimensional tumor modeling and biomarker analysis. In other words, instant steps 6-8 of claim 1 is combining prior art elements according to known methods to yield predictable results. The predictable results namely being the utilization of tumor spheroids (i.e. 3D) instead of single cells (i.e. 2D) in the preparation of tissue reference control. See MPEP 2143 (I)(A).
It is also noted that neither Santo nor Gabriel explicitly teach separating spheroids from single cell prior to the fixation and embedding step (i.e. step 6). However, Santo et al teach that prior to phenotypic characterization ( e.g. screening for apoptotic activity) which involves fixation, embedding, and sectioning, Santo et al teach that spheroids are centrifuged for 5 mins at 200Xg and washed twice with PBS prior to fixation. (See section 2.5.4.2. on page 120). It should be noted that centrifugation and washing twice with PBS is a step that would inherently separate spheroids from single cell suspension, as recited in instant specification ( See paragraph [0037] of instant specification on page 6). Therefore, separating single cell from spheroids prior to fixation and staining is presumed to be inherent in the teachings of Santo et al. It should also be noted that separating single cell from spheroids using the washing and centrifugation steps is a common practice in the art as supported by the teachings of Santo et al.
Regarding claims 2-3,6,8, and 19-20, following the discussion of claim 1 above, Imam et al in view of Kastner et al and Meijdan et al render obvious growing cancer cells to a specific cell-cycle phase to provide cancer cells with various expression level of a specific marker. As previously noted, Imam et al disclose that STMC is constructed to include a plurality of types of cancer cells with varying levels and patterns of expression of markers of interest.(Paragraph [0042]). Imam et al further state that “STC and STMC may be cultured to consistently provide various levels of expressions of biomarkers”, and suggest utilizing immunohistochemical (IHC) staining to detect the expression level of a specific marker in the cocultured cells (See paragraph [ 0035]). Neither Imam nor Kastner or Meijdan explicitly state that the cells should be grown to a phase in which the phase has positivity or negativity for the specific marker, or to a phase where at least 90% of the cells exhibit the level, etc. However, determining a phase where the cells either express a specific marker or do not, discovering an optimal % of cells that express a specific level of expression of biomarkers, or determining the level of expression being high, medium, or negative, these are all claim limitations that are well-understood, routine, and conventional steps in the relevant art. Therefore, one with ordinary skill in the art would be motivated to use routine experimentation to discover an optimum value of a result. The motivation of doing so would be to include various cancer cells with different expression level that can be used as a reference control for cancer diagnosis. One of ordinary skill in the art would be able to arrive at the limitations recited in instant claims through routine experimentation.
As per the MPEP. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219(C.C.P.A. 1980). See MPEP 2144.05.
Regarding claims 5 and 7, the combined teachings of the cited prior arts render obvious growing the cancer cells to a phase prior coculturing. Imam et al further state that “ the STC and STMC are cultured to provide high expression (HE or 3+) of biomarkers used in IHC and ISH staining. In other embodiments, STC and STMC are cultured to have medium expression (ME or 2+) of biomarkers used in IHC and ISH staining. In further embodiments, STC and STMC are cultured to have low expression (LE or 1 +) of biomarkers used in IHC and ISH staining”. (See paragraph [0035]).
Regarding claims 9 and 21, Imam et al teach culturing cancer cells, such as MCF-7, in the presence of insulin to promote the cancer cell proliferation prior to the mixing step (See paragraph [0032]). However, Imam et al do not teach culturing cancer cells prior to the mixing step in growth-factor containing media to increase the expression level of a specific marker in the cancer cells.
Cui et al teach that culturing breast cancer cells in a medium containing epidermal growth factor (EGF) induces the expression the expression of insulin receptor substrate-1 (IRS-2), thereby generating cells exhibiting elevated levels of a selected biomarker. (See abstract).
Taken together, the teachings of Imam et al in view of Cui et al render obvious claims 9 and 21, as there was some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. Imam et al teach a method of making a tissue reference block comprising of co-cultured mixture of normal and cancer cells, but fail to suggest growing the cancer cells prior to the coculturing step in a medium containing growth factor to increase the expression level of a specific marker. Cui et al teach that culturing breast cancer cells in a medium comprising EGF increases the expression level of IRS-2. Therefore, an ordinary skill in the art who had reviewed Imam et al could have come across Cui and immediately noticed the possibility of growing cancer cells of Imam et al in a medium containing a growth factor to increase the expression of a specific marker that can be used in diagnosis. There is a reasonable expectation of success, when making a tissue reference block, to culture the cancer cells of Imam et al in a medium containing a growth factor because doing so would provide cells that express a specific marker that can be used in cancer diagnosis.
Regarding claims 10-12, and 22-24, the method of Imam et al involves coculturing the mixture of cells for about 10 days ( See paragraph [0030]), this reads on claims 12 and 24. Imam et al also state that “ In some embodiments, approximately 80 million stromal cells and/or
cancer cells may be harvested from each cell culture bag after approximately ten days of co-culturing”. Imam et al do not explicitly disclose the ratio or the relative number of normal to cancer cells in the mixture. However, these limitations are also routine in the art and one with ordinary skill in the art at the time the invention was filled would be motivated to use routine experimentation to determine the optimal number or ratio of cells to produce spheroids that resemble the actual tumor tissue.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). See MPEP 2144.05.
Regarding claims 13,16, and 25, Imam et al do not teach cutting a segment from the core and placing it in a recipient block, nor do they teach cutting the entirety of one of the recipient blocks into sections. However, these limitations are also common practice in the relevant art as evidenced by Simon et al. Simon et al teach a method of preparing a recipient tissue microarray. The method involves transferring a segment of paraffin-embedded tissue from a donor block into a recipient block to construct a recipient block consisting of a paraffin tissue microarray ( See Fig.1). Simon et al also teach cutting the recipient blocks into sections and staining it for the presence of specific markers (See Fig.2). Simon et al state that constructing a tissue microarray (TMA) allows for sections from the TMA blocks to be used for simultaneous in situ analysis of hundreds to thousands of tissue samples (See section “Tissue Microarray Technology” on page 98, 2nd column). Therefore, instant claims are combining prior art elements according to known methods to yield predictable results, namely the predictable result is to construct a tissue microarray comprising of patients tissue samples and tissue reference control block of claim 1. Imam et al in view of the cited prior arts render obvious constructing tissue reference control block comprising of co-cultured cancer and normal cells. Simon et al teach a method for constructing a tissue microarray and clearly suggest that the TMA can be used to facilitate the simultaneous analysis of thousands of tissue samples. An ordinary skill in the art would be motivated to combine the teachings of Imam and Simon to generate a TMA comprising of patients samples and the reference control block of Imam et al because doing so would facilitate the analysis of many patient tissue samples at the same time.
Regarding claims 14-15, 17, and 26, Imam et al teach utilizing a recipient block
consisting of a paraffin tissue microarray (See paragraph [0059] ), this reads on claims 14 and 26. The method of Imam et al also involves cutting the paraffin blocks into sections and testing them to determine the presence of various markers used in pathology testing laboratories (See paragraph [0027] ), this reads on claims 15, and 17.
Response to Arguments
Applicant's arguments filed 04/20/2026 have been fully considered but they are not persuasive.
1. It is noted that Applicants amended claim 9 and 21 to recite “ when fewer than about 90% or fewer than 80% of the cancer cells exhibit the level of expression of the specific marker, the cancer cells are grown in a medium containing a growth factor selected from the group consisting of epidermal growth factor, insulin, and insulin-like growth factor, depending upon the cell-type to induce the expression level of the specific marker” in the attempt to overcome the rejection under 35 U.S.C. § l 12(a) . In response to such argument, the office still finds the amendment not enough to overcome the rejection under 35 U.S.C. § l 12(a). This is because, there still no data to show which growth factor, for example EFG or insulin or inulin like growth factor, should be utilized on which cancer cell type to induce the expression of what marker. The claim does not specify which biomarker would be induced by which growth factor. Neither it recites the type of cancer cell type that would fulfill the limitation. The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed. Therefore, the claims as amended still do not overcome the rejection, and hence the rejection of claims 9 and 21 under 35 U.S.C. § l 12(a) is maintained.
2. Applicant further argue that none of the cited prior art teach the limitation of growing cancer cells to "an S phase or a G2M phase" for the purpose of making a tissue reference control block. For example, Applicants argue that while Kastner is cited for teaching that GPRl 9
expression varies with the cell-cycle, Kastner is directed to the study of an orphan G protein coupled receptor in lung cancer cells and its relationship to cell-cycle progression, and does not teach or suggest growing cancer cells to an S phase or a G2M phase as a deliberate step in a method of making tissue reference controls. In other words, Applicant argue that Kastner is directed to an entirely different field of endeavor. In response to this argument, this is also not found persuasive, because the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Applicants are also reminded that according to the MPEP, the obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), andKSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Imam et al disclose a method for making tissue reference control block (i.e. STC and STMC) for IHC and ISH testing by selecting cancer cells with a known positivity or negativity for a specific marker. Kastner and Meijden et al supplement Imam et al by teaching that specific markers is temporally associated with specific stages of cell cycle, and that synchronized cancer cell (i.e. growing cells to a phase) exhibit predictable phase-dependent marker expression. Therefore, it would have been obvious to an ordinary skill in the art to modify the method of Imam et al and use an enriched cancer-cell population for a selected cell-cycle phase to obtain elevated expression of a desired marker before fixation or embedding, because Kasner and Meijden et al expressly teach that some markers reach maximal expression at specific stages of S phase or G2/M phase. The motivation of doing so would be to include cancer cells with elevated expression of a desired marker that can be used as a reference control for cancer diagnosis.
3. Applicants further argue that none of the cited prior arts teach harvesting spheroids or the step of “ "separating the spheroid from a non-spheroid single cell population" . This is also not found persuasive, because Applicants have amended the claim to include the aforementioned limitation, which the office has addressed in the edited rejection above. In other words, an edited rejection is made over Imam et al in view of Kasner and Meijden, that covers the added claim limitations ( as discussed above).
4. Applicants also argue that the claimed combination of steps produces unexpected and superior results that would not have been achieved by routine optimization of the Imam process. This is also not found persuasive, because based on the combined teachings of cited prior art, one with ordinary skill in the art would have predicted that growing a cancer cell to an S-phase or G2M phase would produce a cell that exhibit a predictable phase-dependent marker expression. One with ordinary skill in the art would have also predicted that co-culturing the screened cells into a bioreactor according to Santo teachings would produce spheroids that can be used in preparing the tissue reference block of Imam et al, as taught by Gabriel et al. One with ordinary skill in the art would have predicted similar results presented by instant application upon combining the cited prior arts.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FATIMAH KHALAF MATALKAH whose telephone number is (703)756-5652. The examiner can normally be reached Monday-Friday,7:30 am-4:30 pm EST.
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/FATIMAH KHALAF MATALKAH/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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