DETAILED ACTION
Applicant’s response filed September 23, 2025 has been received and entered into the application file. All arguments have been fully considered. Claims 1, 4-7, 9-12, 15-18, 20-25, 27-29, and 31-33 are currently pending. Claims 2-3, 8, 13-14, 19, 26, and 30 are cancelled. Claims 1, 12 and 23 are currently amended.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/23/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
REJECTION(S) WITHDRAWN
Claim Rejections - 35 USC § 112
RE: Rejection of Claims 1-33 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite:
Applicant’s amendment submitted 9/23/2025 has amended claims 1, 12 and 23 to now clarify the time period for hypoxic exposure is 1 day, or more days, prior to delivering the fibroblasts to the joint between vertebrae and/or intervertebral discs. Thus, Applicant has provided sufficient clarification as to exposure to hypoxic conditions.
It is further noted, as previously set forth, Falanga evidences that that exposing fibroblasts to hypoxic conditions (2% oxygen) results in increased synthesis of TGF-β1 after 48 hours in culture (Abstract and Fig. 1). Falanga further teaches that, upon returning the fibroblasts to standard oxygen conditions (i.e., 15%) for 24 hours, the increased levels of TGF-β1 were reversed (Abstract). Thus, Falanga evidences that fibroblasts “having been exposed to hypoxic conditions” for at least 48 hours would have increased levels of TGF-β1. However, if those fibroblasts are returned to standard culture conditions, the increased levels of TGF-β1 would decline.
The claims as currently written require at least 1 day of hypoxic exposure prior to delivering to the joint, however the claims as currently written do not exclude returning the fibroblasts to normoxic conditions subsequent to the hypoxic exposure.
Claim Rejections - 35 USC § 102/103
RE: Rejection of Claim(s) 1-7, 9-18, 20-29 and 31-33 under pre-AIA 35 U.S.C. 102(a), 102(b) and 102(e) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Song, as evidenced by R&D Systems and as further evidenced by Falanga:
As discussed above, Applicant’s amendment submitted 9/23/2025 has amended claims 1, 12 and 23 to now clarify the time period for hypoxic exposure is 1 day, or more days, prior to delivering the fibroblasts to the joint.
It is noted that Song does not further teach culturing/exposing the fibroblasts to hypoxic conditions for 1 or more days prior to delivering the composition.
Therefore, the rejection is withdrawn in view of Applicant’s amendment.
Claim Rejections - 35 USC § 103
RE: Rejection of Claims 8, 19 and 30 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Song, as evidenced by R&D Systems and Falanga, and further in view of Nishida:
As set forth immediately above, Song does not further teach culturing/exposing the fibroblasts to hypoxic conditions for 1 or more days prior to delivering the composition.
Therefore, the rejection is withdrawn in view of Applicant’s amendment.
NEW GROUND(S) OF REJECTION, NECESSITATED BY AMENDMENT
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 4, 9, 12, 15 and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Attawia et al., (US 2009/0068270; IDS 11/1/2021) (“Attawia”), as evidenced by Castro-Malaspina et al., (Blood, Vol 56, No. 2 (August), 1980; see PTO-892) (“Blood 1980”) and Morikawa et al., (Pfluegers Arch – Eur J Physiol (2016) 468: 13-22; PTO-892) (“Morikawa”).
Regarding claims 1 and 12, Attawia is directed to treating diseased intervertebral discs (i.e., treating an individual in need of cartilage repair) by administering autologous uncultured cells (e.g., fibroblasts) into a diseased intervertebral disc (i.e., joint between vertebrae and/or intervertebral discs) thus providing the patient with immediate point of care treatment (Abstract and [0016]).
Claims 1, 5, 10 and 11 of Attawia claim the following:
A method of treating degenerative disc disease in an intervertebral disc having a nucleus pulposus and annulus fibrosus, comprising transdiscally administering autologous uncultured cells into a degenerated intervertebral disc, wherein said autologous uncultured cells are concentrated by immunoabsorption prior to being administered into said intervertebral disc.
5. The method of claim 1, wherein said autologous uncultured cells comprise fibroblasts.
10. The method of claim 1, wherein said autologous uncultured cells are administered into the nucleus pulposus of the intervertebral disc.
11. The method of claim 1, wherein said autologous uncultured cells are administered into the annulus fibrosus of the intervertebral disc.
Although claims 1, 5, 10 and 11 of Attawia do not further exemplify the composition consists of fibroblasts and an amount of fluid needed to suspend the fibroblasts, it is noted that Attawia, at paragraphs [0061] and [0063] teaches the cells alone can be administered by injection into the intervertebral disc through a needle, wherein the cells are suspended in a growth medium, which reads on “wherein the composition consists of fibroblasts and an amount of fluid needed to suspend the fibroblasts” (claim 1) and “wherein the composition consists essentially of fibroblasts and an amount of fluid needed to suspend the fibroblasts” (claim 12).
Thus, Attawia does render obvious delivery of a composition that consists of fibroblasts and an amount of fluid needed to suspend the fibroblasts, that is, Attawia teaches the limitations required by the current claims and as all limitations are found in one reference it is held that delivery of a composition that consists of fibroblasts and an amount of fluid needed to suspend the fibroblasts is within the scope of the teachings of Attawia, and thus renders the invention of claims 1 and 12 prima facie obvious. The rationale to support this conclusion of obviousness is that the single reference provides the teachings and suggestion to deliver a composition that consists of fibroblasts and an amount of fluid needed to suspend the fibroblasts. Furthermore, there is no evidence on the record that shows that the claimed limitation has any greater or unexpected results than that exemplified by Attawia.
Further as to the limitation the fibroblasts have been exposed to hypoxic conditions, wherein the fibroblasts have been cultured in hypoxic conditions for 1 or more days prior to delivery of the cell composition, it is noted that Attawia teaches the cells are obtained from the patient’s own bone marrow ([0024]-[0026]) and Blood 1980 evidences that bone marrow comprises fibroblasts (Abstract) and Morikawa evidences that bone marrow is inherently a hypoxic environment (Abstract). Thus, in view of Blood 1980 and Morikawa’s teaching, it is noted that Attawia’s disclosed fibroblasts obtained from the patient’s own bone marrow read on fibroblasts having been cultured for 1 or more days in hypoxic conditions prior to delivery to the intervertebral discs, thus meeting the limitation of claims 1 and 12.
Regarding claims 4 and 15, Attawia teaches the cells are administered by injection through a needle at a volume ranging from 0.5 ml to 3.0 ml ([0061]; claims 8 and 13), thus meeting the limitations of claims 4 and 15.
Regarding claims 9 and 20, Attawia teaches administering autologous fibroblasts obtained from the patient’s own bone marrow (Abstract; [0016] and [0024]-[0026]; claim 5).
Claims 5 and 16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Attawia, as evidenced by Blood 1980 and Morikawa, as applied to claims 1, 4, 9, 12, 15 and 20, and further in view of Leckie et al., (Spine J. 2011 Oct 22;12(1):7–20; see PTO-892) (“Leckie”).
The teaching of Attawia, as evidenced by Blood 1980 and Morikawa, is set forth above.
Regarding claims 5 and 16, although Attawia teaches delivery using a needle, Attawia does not further comment on the needle being attached to a syringe. However, Leckie is directed to methods of treating intervertebral disc degeneration wherein the therapeutic agent is delivered into the nucleus pulposus of intervertebral discs (Abstract). Leckie teaches delivering the therapeutic agent to L2-L3 discs using a Hamilton 100-mL syringe and a Hamilton 30-gauge sharp-tipped needle (Injection surgery, left column, page 10). Thus, Leckie has established it was known at the time of filing the invention to deliver therapeutic agents to intervertebral discs by using a needle and syringe.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time of filing the invention to substitute a needle and syringe, as disclosed by Leckie, for Attawia’s disclosed needle since both apparatuses are known to successfully deliver therapeutic agents for treating intervertebral disc degeneration. Therefore, one of ordinary skill in the art would recognize this as simply substituting one type of MSCs for another useful for the same purpose ((KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007) pg 14 and 12).
The skilled artisan would have had a reasonable expectation of success in combining the teachings of Leckie with Attawia because each of these teachings are directed at treating intervertebral disc degeneration.
Claims 6-7, 10, 17-18 and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Attawia, as evidenced by Blood 1980 and Morikawa, as applied to claims 1, 4, 9, 12, 15 and 20, and further in view of Singh et al., (Journal of Biomedical Materials Research Part A, September 1, 2011, Vol. 98A, issue 3, pp. 412-424; IDS 11/1/2021) (“Singh”).
The teaching of Attawia, as evidenced by Blood 1980 and Morikawa, is set forth above.
Regarding claims 6-7 and 17-18 and the limitations directed to the fluid needed to suspend the fibroblasts comprises buffer, amino acids, salts, glucose and/or vitamins (claims 6 and 17) and said buffer, amino acids, salts, glucose and/or vitamins are components of DMEM (claims 7 and 18), it is noted that although Attawia teaches the fluid needed to suspend the fibroblasts comprises a cell culture growth medium ([0063]), Attawia does not further comment on the growth medium comprising components of DMEM. However, Singh is directed to evaluating human dermal fibroblasts as a potential cell source for treating intervertebral disc repair (Abstract) and teaches the use of DMEM as a growth medium for the human fibroblasts (page 2, Cell expansion).
Thus, Singh has established it was known at the time of filing the instant invention to use DMEM as a growth medium for therapeutic fibroblasts. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time of filing the invention to substitute DMEM growth medium for Attawia’s disclosed growth medium since both are known fibroblast growth mediums. Therefore, one of ordinary skill in the art would recognize this as simply substituting one type of fibroblast growth medium for another useful for the same purpose ((KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007) pg 14 and 12).
The skilled artisan would have had a reasonable expectation of success in combining the teachings of Singh with Attawia because each of these teachings are directed at using fibroblasts for disc degeneration therapy.
Further regarding claims 10 and 21 and the limitations directed at the source of the fibroblasts, it is noted that Attawia teaches obtaining the therapeutic cells from bone marrow and does not further teach obtaining the fibroblasts from the tissues recited in claims 10 and 21. However, as set forth immediately above, Singh is directed to evaluating human dermal fibroblasts as a potential cell source for treating intervertebral disc repair (Abstract).
Thus, Singh has established it was known at the time of filing the instant invention to use dermal fibroblasts for intervertebral disc repair. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time of filing the invention to substitute dermal fibroblasts, as taught by Singh, for Attawia’s disclosed bone marrow-derived fibroblasts. One of ordinary skill in the art would recognize this as simply substituting one type of fibroblast for another useful for the same purpose ((KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007) pg 14 and 12).
The skilled artisan would have had a reasonable expectation of success in combining the teachings of Singh with Attawia because each of these teachings are directed at using fibroblasts for disc degeneration therapy.
Claims 11 and 22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Attawia, as evidenced by Blood 1980 and Morikawa, as applied to claims 1, 4, 9, 12, 15 and 20, and further in view of Song et al., (previously cited).
The teaching of Attawia, as evidenced by Blood 1980 and Morikawa, is set forth above.
Regarding claims 11 and 22 and the limitation the fluid is not media, it is noted that Attawia does not further teach the fluid is not media. However,
Song is directed to methods of treating an individual in need of cartilage regeneration, wherein fibroblasts are administered via intra-articular injection to an arthritic joint space. Song’s therapeutic fibroblasts contain a vector encoding a transgene (e.g., TGF-β1) (Abstract and [0067], [0115], [0150], [0154]), wherein the TGF-β1 secreted by the injected fibroblasts stimulated hyaline cartilage regeneration in the damaged area by producing the TGF-β receptors at their cell surface ([0110]).
Song teaches the pharmaceutical forms suitable for injectable use include sterile aqueous solutions for easy syringability (fluid needed to suspend fibroblasts), and, in many cases, it will be preferable to include isotonic agents, for example, sugars or sodium chloride (salts) ([0128]).
Thus, Song has established it was known at the time of filing the instant invention to use resuspension fluid that is not culture media. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time of filing the invention to substitute aqueous solutions that are not media, as taught by Song, for Attawia’s disclosed growth media. One of ordinary skill in the art would recognize this as simply substituting one type of fibroblast resuspension fluid for another useful for the same purpose ((KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007) pg 14 and 12).
The skilled artisan would have had a reasonable expectation of success in combining the teachings of Song with Attawia because each of these teachings are directed at using fibroblasts for cartilage regeneration.
Claims 23-25 and 31 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Singh et al., (Journal of Biomedical Materials Research Part A, September 1, 2011, Vol. 98A, issue 3, pp. 412-424; IDS 11/1/2021) (“Singh”).
Singh teaches dermal fibroblasts as another cell source for cartilage tissue engineering, including for IVD (intervertebral disc) repair and regeneration since tissue regeneration strategies leveraging dermal fibroblasts presents several potential advantages since (1) these cells can be easily isolated in a noninvasive and patient-specific manner, and (2) there is a relatively abundant supply (INTRODUCTION, page 1). Singh’s study investigated: (1) cell viability and chondrogenic differentiation of the cells using dynamic hydrostatic pressure and/ or hypoxia as chondrogenic signals and (2) effects of combined biochemical (BMP-2) and biomechanical stimulations on chondrogenic differentiation in hypoxic/normoxic conditions (page 10, DISCUSSION, left col, first paragraph).
Regarding claim 23, Singh teaches evaluating neonatal human dermal fibroblasts (nHDFs) as a potential cell source for treating intervertebral disc repair (Abstract), wherein autologous nHDFs encapsulated in a degradable hydrogel structure and exposed for a brief period (up to 21 days, i.e., fibroblasts are cultured for 1 or more days in hypoxic conditions prior to delivering the composition) to the combination of hydrostatic compression, hypoxia, and BMP-2 can be directly transplanted in vivo following nucleus aspiration/removal, i.e., treating an individual in need of cartilage repair (page 11, right col, last paragraph; FIGURE 4). Singh teaches hypoxia (2% O2) has been found to influence human dermal fibroblasts grown in monolayers by up-regulating the synthesis of transforming growth factor (TGF)-β1 which is a known chondrogenic factor (page 2, left col, first full paragraph).
Singh teaches the nHDFs were isolated from foreskin tissue and cultured in DMEM for up to 21 days under hypoxic conditions (5% O2) (Abstract; page 2, left col, last paragraph; page 2, Experimental design and Cell expansion; page 3, Bead culture), which reads on “…isolating and culturing fibroblasts from a biopsy from a donor…” and “…wherein the fibroblasts are cultured in hypoxic conditions for 1 or more days prior to delivering the composition…”.
Although Singh does not exemplify delivering the fibroblasts to a joint between vertebrae and/or intervertebral discs, it is noted as set forth above, Singh clearly suggests in vivo (intervertebral) delivery of nHDFs that have been cultured under hypoxic conditions for up to 21 days (page 11, right col, last paragraph).
Thus, Singh does render obvious delivering the fibroblasts to a joint between vertebrae and/or intervertebral discs, that is, Singh teaches the limitations required by the current claims and as all limitations are found in one reference it is held that delivering the fibroblasts to a joint between vertebrae and/or intervertebral discs is within the scope of the teachings of Singh, and thus renders the invention of claim 23 prima facie obvious. The rationale to support this conclusion of obviousness is that the single reference provides the teachings and suggestion to deliver the fibroblasts to a joint between vertebrae and/or intervertebral discs. Furthermore, there is no evidence on the record that shows that the claimed limitation has any greater or unexpected results than that exemplified by Singh.
Regarding claim 24, although Singh exemplifies neonatal human dermal fibroblasts purchased from Invitrogen, Singh suggests autologous transplant (page 11, right col, last paragraph). Thus, Singh does render obvious the donor is the individual, that is, Singh teaches the limitations required by the current claims and as all limitations are found in one reference it is held that delivering autologous fibroblasts to a joint between vertebrae and/or intervertebral discs is within the scope of the teachings of Singh, and thus renders the invention of claim 24 prima facie obvious. The rationale to support this conclusion of obviousness is that the single reference provides the teachings and suggestion to deliver autologous fibroblasts to a joint between vertebrae and/or intervertebral discs. Furthermore, there is no evidence on the record that shows that the claimed limitation has any greater or unexpected results than that exemplified by Singh.
Regarding claim 25, Singh’s cultured fibroblasts are obtained from a skin biopsy of human foreskin (page 2, Cell expansion), thus meeting the limitation of claim 25.
Regarding claim 31, Singh teaches in vivo transplantation (i.e., injection) of the therapeutic fibroblasts (page 11, right col, last paragraph), thus meeting the limitation of claim 31.
Claims 27-29 and 33 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Singh, as applied to claims 23-25 and 31 above and further in view of Song et al., (previously cited), and as evidenced by R&D Systems (Dulbecco’s Modified Eagle’s Medium (DMEM) Product Description, 2 pages, previously cited) (“R&D Systems”).
The teaching of Singh is set forth above.
Regarding claims 27-29 and 33, although Singh teaches in vivo transplantation of the therapeutic fibroblasts, Singh does not further teach whether or not the fibroblasts are suspended in an amount of fluid for in vivo transplantation (claim 27), wherein the fluid comprises buffer, amino acids, salts, glucose, and/or vitamins (claim 28), or wherein the buffer, amino acids, salts, glucose, and/or vitamins are components of DMEM (claim 29), or wherein the fluid is not media (claim 33).
However, Song is directed to methods of treating an individual in need of cartilage regeneration, wherein fibroblasts are administered via intra-articular injection to an arthritic joint space. Song’s therapeutic fibroblasts contain a vector encoding a transgene (e.g., TGF-β1) (Abstract and [0067], [0115], [0150], [0154]), wherein the TGF-β1 secreted by the injected fibroblasts stimulated hyaline cartilage regeneration in the damaged area by producing the TGF-β receptors at their cell surface ([0110]).
Song teaches the pharmaceutical forms suitable for injectable use include sterile aqueous solutions for easy syringability (i.e., an amount of fluid needed to suspend fibroblasts prior to delivering the fibroblasts), and, in many cases, it will be preferable to include isotonic agents, for example, sugars or sodium chloride (salts) (i.e., the fluid is not media) ([0128]).
Thus, Song has established it was known at the time of filing the instant invention to use resuspension fluid that is not culture media, e.g., salts. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time of filing the invention to include using use resuspension fluid that is not culture media, as disclosed by Song.
The person of ordinary skill in the art would have been motivated to modify the method of Singh to deliver the fibroblasts using a resuspension fluid that is not culture media for the predictable result of providing syringibilty and easy delivery of the fibroblasts to the intervertebral disc, thus meeting the limitations of claims 27-28 and 33.
The skilled artisan would have had a reasonable expectation of success in combining the teachings of Singh and Song because each of these teachings are directed at treating intervertebral disc degeneration.
Further regarding claim 29 and the limitation “wherein the buffer, amino acids, salts, glucose, and/or vitamins are components of DMEM”, it is noted that R&D Systems evidences the formulation for DMEM comprises sodium chloride (INORGANIC SALTS, page 2 of 2). Thus, Song’s disclosed solution of sodium chloride is a component found in DMEM, thus meeting the limitations of claim 29.
Claim 32 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Singh, as applied to claims 23-25 and 31, and further in view of Leckie et al., (Spine J. 2011 Oct 22;12(1):7–20; see PTO-892) (“Leckie”).
The teaching of Singh is set forth above.
Regarding claim 32, although Singh teaches delivery via in vivo intervertebral transplantation (i.e., injection) to the nucleus, Singh does not further comment on using a syringe. However, Leckie is directed to methods of treating intervertebral disc degeneration wherein the therapeutic agent is delivered into the nucleus pulposus of intervertebral discs (Abstract). Leckie teaches delivering the therapeutic agent to L2-L3 discs using a Hamilton 100-mL syringe and a Hamilton 30-gauge sharp-tipped needle (Injection surgery, left column, page 10). Thus, Leckie has established it was known at the time of filing the invention to deliver therapeutic agents to intervertebral discs by using a needle and syringe.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time of filing the invention to include using a syringe, as disclosed by Leckie.
The person of ordinary skill in the art would have been motivated to modify the method of Singh to deliver the fibroblasts using a syringe for the predictable result of precise delivery of the therapeutic fibroblasts to the intervertebral disc, thus meeting the limitation of claim 32.
The skilled artisan would have had a reasonable expectation of success in combining the teachings of Singh and Leckie because each of these teachings are directed at treating intervertebral disc degeneration.
Response to Remarks
Rejection under 35 USC 103:
Applicant’s remarks have been carefully considered, but are not found persuasive in view of the new grounds of rejection set forth above and addressing the newly amended limitations regarding fibroblasts having been cultured in hypoxic conditions for 1 or more days prior to delivering the fibroblast composition, and wherein the joint comprises a joint between vertebrae and/or intervertebral discs.
Conclusion
No claim is allowed. No claim is free of the prior art.
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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Any inquiry concerning this communication or earlier communications from the examiner should be directed to E. YVONNE PYLA whose telephone number is (571)270-7366. The examiner can normally be reached M-F 9am - 6pm.
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E. YVONNE PYLA
Primary Examiner
Art Unit 1633
/EVELYN Y PYLA/ Primary Examiner, Art Unit 1633