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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on Oct. 16, 2024, has been entered.
Notice of New Examiner
Note that the correspondence for this application has changed (please see the correspondence section at the end of the office action).
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. KR10-2018-0033828, filed on Sept. 23, 2020.
Claim Status
In the reply filed on Sept. 17, 2024, Applicant has amended claim 1, filed new claims 18-24, and canceled claims 3, 9-14, and 16.
Currently, claims 1-2, 4-8, 15, and 17-24 are under examination.
Claim Objections
Claim 1 is objected to because of the following informalities: reciting the words “natural killer” in first recitation of the abbreviation NK cells. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: missing a period at the end of the claim. Appropriate correction is required.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/16/2024 was filed after the mailing date of the Advisory Action on 10/16/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, and 19-24 rejected 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.
Claim 1 recites the claim limitation of “(d) inoculating a bioreactor with the cell culture comprising NK cells and culturing by stationary culture and then suspension culture sequentially”. However, this limitation in the claim renders the claim indefinite because it is unclear which population of NK cells that the Applicant is referring to in the claim (i.e. the NK cells from step (a) or step (c)). As such the claim is indefinite because it is not apparent to what cell culture comprising NK cells that the Applicant is referring to in step (d). The indefiniteness of claim would be cured if the claim limitation recited for example, the cell culture comprising the NK cells of step (c). For compact prosecution, the claim limitation will be interpreted as the cell culture comprising the NK cell of step (c), which were cultured by stationary culture and then suspension culture, sequentially.
Claims 20, and 23-24 recites the limitation “wherein the cell culture is carried out until the cell density" reaches a certain amount. However, this limitation in the claim renders the claim indefinite because it is unclear if the Applicant is referring to the NK cells or the feeder cells or the mononuclear cells in the cell culture. As such the claim is indefinite because it is not apparent to what “cell” the Applicant is referring to in the cell culture.
Furthermore, the issue propagates in Claims 19 and 21-22, which require a lower concentration of cells, where claim 23 has a cell density of about 0.4-1.0x106 cells/mL and claims 24 has a reduced cell density of about 0.7x106 cells/mL. Given that the claims are to a method of producing NK cells it is unclear if the “cells” in claims 23 and 24 are referring to the total cells in culture or the NK cells of claims 21 and 22. Therefore, it appears that there is a loss of total cells or NK cell in the cell culture. Furthermore, it is unclear why there is a lower density of NK cells unless the method is losing cells. For compact prosecution, the claims will be interpretated as the density of total cells in the cell culture.
Claim Interpretation
Claim 1 recites the phrase “accumulated population doubling level” and describes a level of 3-5. As defined in the specification, “The accumulated population doubling level (aPDL) of cells means the number of cell divisions after thawing” (paragraph [0107], page 24, lines 7-9). Therefore, a level of 3-5 means that the cells have had 3 to 5 divisions since thawing.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4-8, 15, 17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Min et al. (WO2016/085248A1, 2016, on IDS 08/11/2021, prior art of record) in view of Min et al., (WO2013/094988A1, published 2013, cited IDS 08/11/2021; hereinafter as “Min 2013”), Eibl et al., (Disposable bioreactors: 55-87; published 2009), and Alici (US2012/0258085A1; published 2012).
Regarding claim 1, preamble, Min discloses a method for producing Natural Killer (NK) cells (see e.g. abstract, claim 1, paras. 11 and 88-95, figs. 1-5; Examples 1-2).
Regarding claim 1, step (a), Min teaches a method wherein NK cells (mononuclear cells) are stimulated with feeder cells and stationary-cultured (see e.g. para. 88). Regarding to step (b), Min teaches that following this, the stationary-cultured cells were cultured in suspension culture and restimulated with feeder cells (see e.g. para. 89 and 94). Regarding step (c), Min teaches that for re-stimulation, NK cells and feeder cells can be co-cultured in suspension culture (see e.g. para. 95).
While Min does not explicitly state the specific number of doublings for when cells are restimulated, it should be noted that the claims do not require a specific number of cells, but only require a number of doublings. Min teaches that the addition of feeder cells leads to fold increases ranging from 21-fold to as high as 2752-fold (see e.g. para. 90-90, 96-97, and 103), and that previous method result in 3 to 10-fold increase in NK cells (see e.g. para. 6). Min also teaches that once frozen thawed mononuclear cells can be used as starting cells (see e.g. para. 74). Therefore, the fold-increases, as taught by Min, overlap with the doublings of 3-5 times (for thawed cells) as in claim 1.
Additionally, providing context for a workable example, the specification states that in one example, cells were counted and diluted to a concentration of 2 x 105 to 5 x 105 before restimulation (see e.g. para. 97, page 37, lines 20-23). In comparison, Min teaches that for restimulation, cells are diluted to a density of 2-5 x 102, and recounted and diluted at intervals of 2-3 days in suspension culture at the same density, up to 21 days (see e.g. para. 94).
Therefore, it appears that if Min does not teach a timing of restimulation at a doubling of 3-5 times, the method of Min is at least capable of performing the restimulation step at this timing.
Moreover, a person of ordinary skill in the arts could have arrived at a timing of re-stimulating the cells when the accumulated population level of mononuclear cells reaches 3-5 by routine optimization, and the disclosure does not point to a criticality in this regard (see MPEP 2144.05(II)(A)). In the instant case, because, as above, Min teaches that the addition of feeder cells leads to fold increases ranging from 21-fold to as high as 2752-fold (see e.g. para. 90-90, 96-97, and 103), which overlaps with doublings of 3-5 times, a person of ordinary skill in the art could have arrived at this timing by routine optimization with predictable results and a reasonable expectation of success.
Regarding claims 1, 15, and 17, Min is silent as to the speed at which cells are agitated in suspension culture.
However, Min cites the prior art of Min 2013 (WO2013094988A1)(see page 3), which teaches that bioreactors (i.e. reactors, e.g. Wave bioreactor) are commonly used for suspension cultures (see e.g. pages 7-8). Further, the prior art of Eibl discloses that bioreactors (e.g. Wave bioreactor) have optimum mass and energy transfer within the mechanically driven inflated culture bag, and the essential parameters such as rocking rate, rocking angle, vibration frequency, temperature and aeration rate are adjustable (see e.g. abstract and page 58).
Regarding claims 1, 15, and 17, Eibl discloses bioreactors (e.g. Wave bioreactors) for suspension culturing at an agitation speed of 30-300 rpm (see e.g. page 63, table 2).
Accordingly, it would have been obvious for a person of ordinary skill in the art to have modified the methods of Min to incorporate the suspension culturing as taught by Min 2013 and Eibl at the agitation speed of 30-300 rpm (or 60-160 rpm as in claim 17) as taught by Eibl because Eibl discloses that bioreactors (e.g. Wave bioreactor) are common devices in modern biotechnological processes that enable middle to high cell density and adequate productivity in laboratory and pilot scale (see e.g. abstract). Additionally, Min 2013 discloses examples of the reactor for suspension culture include, but are not limited to, a wave bioreactor (GE Healthcare), and a disposable shaker flask (Erlenmeyer) and so on (see e.g. pages 7-8). Therefore, a person of ordinary skill in the art would have incorporated the agitation speed of 30-300 rpm in the suspension culture, which would have led to predictable results with a reasonable expectation of success because both Min, Min 2013, and Eibl disclose that bioreactors are known to be used with suspension culturing. Furthermore, an artisan of ordinary skill in the art of (i.e. suspension-cultured cells) has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
Min is silent regarding inoculating a bioreactor with the cell culture comprising the NK cells that were obtained by stationary culture and then suspension culture sequentially.
However, the prior art of Alici teaches expansion of natural killer cells in a closed automated culture system, for example using a bioreactor (see e.g. para. 1, abstract, and claim 1).
Regarding claim 1, Alici discloses inoculating NK cells (i.e. isolated cells from mononuclear cells) to a bioreactor for expansion, which reads on the claim limitation of inoculating a bioreactor with the cell culture comprising the NK cells that were obtained from culturing by stationary culture and then suspension culture sequentially (see e.g. claims 26, 44; para.23-32, 56-57, 73, and Example 1, fig. 3-4).
Accordingly, it would have been obvious for a person of ordinary skill in the art to have modified the methods (as taught by Min) to incorporate the step of inoculating a bioreactor with the cell culturing comprising NK cells that were obtained by stationary culture and then suspension culture as taught by Alici with a reasonable expectation of success. A person of ordinary skill in the art would have been motivated to do so because Alici discloses that the bioreactor system has “shown suboptimal efficiency when started in low volumes and low cell numbers” (see para. 56). Further, Alici states that “the amount of cells in peripheral blood samples of donors does not allow directly starting in the bioreactor” (see e.g. para. 56). Additionally, as discussed above, Min cites the prior art of Min 2013 (WO2013094988A1) and discloses that reactors (i.e. bioreactors) are known for use in suspension culture methods with NK cell (see e.g. pages 7-8). Therefore, inoculating the bioreactor with the cell culture comprising NK cells that were obtained by stationary culture and then suspension culture, would have been done with predictable results and a reasonable expectation of success. Furthermore, an artisan of ordinary skill in the art of (i.e. expansion of NK cells) has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
Regarding claim 2, Min teaches that cells can be cultured in suspension culture after 3-5 days (of stationary culturing) (see para. 89) or day 7 (see para. 94), which overlaps with the ranges as in claim 2 (MPEP 2144.05(I)).
Regarding claims 4-5, Min teaches that the methods can be performed in the presence of anti-CD3 antibodies OKT3, UCHT1, and HT3a (see e.g. claim 11, para. 56).
Regarding claim 6, Min discloses that the culturing of the step (a) is performed in a medium to which one or more cytokines selected from the group consisting of IL-2, IL-12, IL-15, Il-18, and IL-21 (see e.g. claim 12, para. 57) is added.
Regarding claim 7, Min teaches that the feeder cells may be inactivated T cells (i.e. a type of peripheral blood monocular cell (PBMC)) (see e.g. para. 53).
Regarding claim 8, Min discloses that the CD3-positive cells from the PBMC may be depleted (i.e. removed) (see e.g. page 4, paras. 19-27, 55; figs. 1-3).
Regarding claim 15, as discussed above, Min teaches a NK cell produced by the method according to claim 1 (see e.g. abstract, claim 1, paras. 11 and 88-95, figs. 1-5; Examples 1-2).
Regarding claims 19-20, Min discloses the cell density reaches 5-10x105 cells/mL (i.e. 500,000-1million), corresponding to the claim limitation of the cell culture is carried out until the cell density reaches 0.4-1.0x106 cells/mL (i.e. 400,000-1million)(see e.g. para. 89, 95, Example 2).
Min is silent regarding the concentration of NK cells in the bioreactor at the time of the inoculation.
However, Alici teaches adding the concentration of NK cells to a bioreactor at a concentration of about 0.5×106 to about 2×106 cells/mL (i.e. 500,000-2million) (see e.g. para. 22 and 56), corresponding to the claim limitation of the cell culture is carried out until the cell density reaches 0.1-2.0x106 cells/mL (i.e. 100,000-2million).
Accordingly, it would have been obvious for a person of ordinary skill in the art to have modified the methods of Min to incorporate the cell concentration as taught by Alici because Alici teaches methods for a closed system (i.e. bioreactor) for large scale expansion and simultaneous activation of natural killer (NK) cells (see e.g. para. 10). Further, Incorporating the concentration of NK cells in the bioreactor as taught by Alici would have led to predictable results with a reasonable expectation of success because Min, which cites the prior art of Min 2013, discloses that it was known to produce NK cells with bioreactors (see e.g. pages 7-8). Therefore, incorporating the NK cell concentration of Alici in the method of culturing NK cells as taught by Min would have led to predictable results with a reasonable expectation of success. Additionally, both Min and Alici teach obtaining an effective amount of NK cells to be used for therapeutic purposes (i.e. para. 10 and claim 23, respectively). Furthermore, an artisan of ordinary skill in the art of (i.e. NK cell culture methods) has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Claims 18, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable Min et al. (WO2016/085248A1, 2016, on IDS 08/11/2021, prior art of record) in view of Min et al., (WO2013/094988A1, published 2013, cited IDS 08/11/2021; hereinafter as “Min 2013”), Eibl et al., (Disposable bioreactors: 55-87; published 2009), and Alici (US2012/0258085A1; published 2012), as applied to claims 1-2, 4-8, 15, 17, and 19-20 above, and further in view of and Somerville, et al. (Journal of translational medicine 10: 1-11; published 2012).
The teachings of Min et al., apply here as indicated above.
Regarding claims 18 and 21, as discussed above, Min cites the prior art of Min 2013 (WO2013094988A1), which discloses that bioreactors are commonly used for suspension cultures (see e.g. pages 7-8).
Min is silent regarding the bioreactor’s pH, temperature, and agitation power.
However, the prior art of Eibl discloses that bioreactors (e.g. Wave bioreactor) have essential parameters such as rocking rate, rocking angle, vibration frequency, temperature and aeration rate, which are adjustable (see e.g. abstract, page 58 and fig. 2).
Regarding claims 18 and 21, Eibl discloses the bioreactors (e.g. Wave bioreactors as cited in the specification, see para. 56) have an agitation power per unit volume of 0.1-100 W/m3 (see e.g. pages 64-66, figs. 3-4), and temperature between 20-37°C (see e.g. page 62, fig. 2). Further, the prior art of Alici discloses that agitation and heating is at a temperature of about 36-40°C (see e.g. para. 16 and 57). Additionally, a person of ordinary skill in the arts could have arrived at the temperatures by routine optimization.
In regard to routine optimization, MPEP 2144.05(II)(A) states, “generally differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); In re Williams, 36 F.2d 436, 438 (CCPA 1929) (‘It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.’)”.
Accordingly, it would have been obvious for a person of ordinary skill in the art to have modified the methods of Min to incorporate the bioreactor temperature and agitation power as taught by Eibl and Alici because Eibl teaches that the bioreactor system setting can be adjusted and controlled (see e.g. abstract, page 58 and fig. 2). Incorporating the bioreactor settings as taught by Eibl and Alici with the methods of Min would have led to predictable results with a reasonable expectation of success because Min, Eibl, and Alici disclose culturing a suspension culture in a bioreactor (i.e. Wave bioreactor) was well a well-known technique. Therefore, a person of ordinary skill in the art would have incorporated the optimal bioreactor settings (i.e. temperature and agitation power), which would have led to predictable results with a reasonable expectation of success. Furthermore, an artisan of ordinary skill in the art of (i.e. suspension-culturing) has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
Eibl and Alici both do not explicitly state that the bioreactor is controlled to pH of 6.5-7.6.
However, the prior art of Somerville teaches the expansion of lymphocytes in a bioreactor (i.e. Wave bioreactor).
Regarding claims 18 and 21, Somerville discloses that the pH of the media was monitored daily throughout the duration of the expansion, which fluctuated within a narrow range around pH 7.2 (see fig. 1c), which reads on the claimed pH 6.5-7.6 (see e.g. page 3-4, fig. 1c).
Accordingly, it would have been obvious for a person of ordinary skill in the art to have modified the methods of Min with the pH range as taught by Somerville with a reasonable expectation of success. A person of ordinary skill in the art would have been motivated to do so because Somerville teaches that the bioreactor creates a more stable culture environment for rapidly expanding lymphocytes (see e.g. page 4, fig. 1 legend). As Min teaches that NK cells are known peripheral blood lymphocytes (para. 4) and Somerville teaches that the culture conditions for lymphocytes were more stable in the bioreactor (i.e. Wave bioreactor) (see e.g. page 4, fig. 1 legend), it would have been obvious to have the bioreactor control the pH with a reasonable expectation of success.
Regarding claims 21-24, as discussed above, Min cites the prior art of Min 2013 (WO2013094988A1), where peripheral blood mononuclear cells are re-stimulated twice or more with feeder cells to produce NK cells and discloses that bioreactors are commonly used for suspension cultures (see e.g. pages 7-8).
Min is silent regarding the concentration of NK cells in the bioreactor at the time of the inoculation.
However, Alici teaches adding the concentration of NK cells to a bioreactor at a concentration of about 0.5×106 to about 2×106 cells/mL (i.e. 500,000-2million) (see e.g. para. 22 and 56), corresponding to the claim limitation of the cell culture is carried out until the cell density reaches 0.1-2.0x106 cells/mL (i.e. 100,000-2million).
Accordingly, it would have been obvious for a person of ordinary skill in the art to have modified the methods of Min to incorporate the cell concentration as taught by Alici because Alici teaches methods for a closed system (i.e. bioreactor) for large scale expansion and simultaneous activation of natural killer (NK) cells (see e.g. para. 10). Further, Incorporating the concentration of NK cells in the bioreactor as taught by Alici would have led to predictable results with a reasonable expectation of success because Min, which cites the prior art of Min 2013, discloses that it was known to produce NK cells with bioreactors (see e.g. pages 7-8). Therefore, incorporating the NK cell concentration of Alici in the method of culturing NK cells as taught by Min would have led to predictable results with a reasonable expectation of success.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments with respect to the pending rejections, filed Sept. 17, 2024, are acknowledged, considered and have been deemed unpersuasive.
Applicants assert that claims 1, 2, 4-8, 15, and 17, and new claims 18-24 are patentable over Min et al. (WO2016085248Al) in view of Mock et al. (Cytotherapy, 2016), and respectfully traverses (Remarks, page 5). Applicant argues that claim 1 has been amended to “recite that the method further comprises step (d) and submits that neither Min nor Mock, nor the combination thereof, teaches or suggests the method of claim 1, comprising "(d) inoculating a bioreactor with the cell culture comprising NK cells and culturing by stationary culture and then suspension culture sequentially." (Remarks, page 5).
Applicant’s arguments, with respect to the previous rejection has been fully considered and are persuasive in view of the amendments to the claims. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Min et al. (WO2016/085248A1, 2016, on IDS 08/11/2021, prior art of record) in view of Min et al., (WO2013/094988A1, published 2013, cited IDS 08/11/2021; hereinafter as “Min 2013”), Eibl et al., (Disposable bioreactors: 55-87; published 2009), and Alici (US2012/0258085A1; published 2012), and further in view of and Somerville, et al. (Journal of translational medicine 10: 1-11; published 2012).
Applicant asserts “as described in the specification, the claimed methods have "an advantage that NK cells having a high cell-killing ability and cell survival rate can be produced with high purity and at high efficiency in a short period of time by a clinically friendly method as compared with existing methods, thereby increasing the productivity of an NK cell therapy
agent"(Remarks, page 5).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., high cell-killing ability, survival rate, and high efficiency in a short period of time) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Furthermore, in response to applicant's argument that the specification describes advantages of the NK cells compared to existing methods, 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).
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPHINE GONZALES whose telephone number is (571)272-1794. The examiner can normally be reached M-Th: 9AM - 5:00PM (EST).
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/JOSEPHINE GONZALES, Ph.D./ Examiner, Art Unit 1631
/JAMES D SCHULTZ/ Supervisory Patent Examiner, Art Unit 1631