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 .
Applicant’s amendments and arguments of February 26, 2026, are entered.
Claims 12 and 20 have been amended.
Claims 1-7 and 25-26 have been canceled.
No new claims have been added.
Status of Claims
Claims 12-20 and 23-24 are pending.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on March 4, 2026, was filed before the mailing of the Final Office Action on May 2, 2026. The Non-Patent Literature is in compliance with the provisions of CFR 1.97 and are being considered by the examiner.
Claim Objections
The objections to claim 1 is withdrawn. Applicant canceled claim 1.
Claim Rejections - 35 USC § 101
The rejections to claims 1-7 being rejected under 35 U.S.C. §101 due to the claimed invention being directed to non-statutory subject matter is withdrawn. Applicant canceled claims 1-7.
Claim Rejections - 35 USC § 112
The rejection to claims 20, 23, and 24 being rejected under 35 U.S.C. §112(a) or 35 U.S.C. §112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is mostly nearly connected, to make and/or use the invention is maintained.
The Nature of the Invention:
Claim 20 recites a method for treating pain to a subject in need. The invention relates to administering mesenchymal stem cells with increased expression of certain proteins, i.e. PTX-3, TIMP1, or BDNF, and administering these mesenchymal stem cells to “treat” pain in a subject in need thereof.
Breadth of the claims:
Claim 20 broadly covers the treatment of pain in a subject in need thereof. Applicant’s specification states that mesenchymal stem cells expressing PTX-3 “have excellent…pain reduction capacity” [pg. 7 ¶ 4]. This language extends the claim scope to virtually all types of pain that arise from various causes that are not associated with inflammation related to arthritis pain. The claim language, similar to the rejection in the Non-Final Office Action, extends pain resulting from such things as headaches, bone fractures, compression injuries, etc., given that pain is mechanistically diverse that includes inflammatory, neuropathic, post-traumatic, visceral, and chronic types.
Amount of Direction or Guidance Present in the Application:
Aside from general statements that mesenchymal stem cells exhibiting increased levels of PTX-3 can reduce pain, the specification does not provide disease-specific or pain protocols, dosing guidance, mechanistic rationales, or administration parameters. There are no examples of mesenchymal stem cells treating pain other than one instance in the specification related to arthritis-induced pain in an animal model. The only other definitive statement about “pain” is that mesenchymal stem cells that exhibit increased levels of the naturally occurring PTX-3, TIMP1, or BDNF “have excellent inflammation inhibition or pain reduction” [pg. 7 ¶ 4]. Aside from the animal model discussed in Example 4, Applicant’s specification does not discuss any other pain models, dosing administration methods related to certain types of pain, e.g. cluster headaches, or any other pain measurement methods used. This is especially true since the only example provided was measuring pain on an animal model based on weight distribution.
Presence of Working Examples:
The only working example is provided in Example 4 on page 22 involving rat models with induced-arthritis pain. The rat model was created by anesthetizing and then injecting 2 mg of monoiodoacetate into the intra-articular knee region. 4 days after that, mesenchymal stem cells expressing PTX-3 were injected with 1% hyaluronic acid in the same region of the induced arthritis pain. This also included a control group that was administered only hyaluronic acid. Pain was then measured using an incapacitance test performed at days 0, 1, 4 ,7, 14, 21, and 28 after the monoiodoacetate injection. There was also a negative control group where umbilical vein endothelial cells exhibiting low PTX-3 were administered to the negative control group. This group was also administered the capacitance test at the respective days [pg. 22]. Pain was then measured in all three groups based on a weight-bearing distribution percentage [Id.]. However, there are no other examples of inflammatory diseases. There are no examples showing the efficacy of mesenchymal stem cells with increased expression of TIMP1 or BDNF. There were no other examples related to a reduction in pain other than the arthritis-induced pain in the animal/rat models, and there were no examples given where mesenchymal stem cells with increased expression of these proteins reduced pain in chronic, neuropathic, traumatic, visceral, or systemic pain.
Relative Skill in the Art:
It is argued that the relative skill in the art, is that of a scientist with several years’ experience in the field, but that the Art itself is a recognition of what is understood by the Artisan, and thus, as seen below, does not make the breadth of the claim more predictable.
The Predictability or Lack thereof in the Art:
The therapeutic effects of mesenchymal stem cells in inflammatory and pain conditions are highly unpredictable. Mesenchymal stem cells behave differently in different microenvironments, and numerous prior art clinical trials show inconsistent or absent efficacy. For example, Weiss et al., discussing a placebo-controlled mesenchymal stem cell randomized trial on the effects in COPD, discloses that there are no statistically significant clinical benefit in treated subjects, and that the COPD subjects treated with mesenchymal stem cells showed no quantifiable improvement in lung function, reduced systemic inflammation, or quality-of-life measurements, including reduced pain, compared to the placebo controls [Results ¶ 1, A placebo-controlled, randomized trial of mesenchymal stem cells in COPD, Chest, 2012]. The trial showed no reduction in COPD-associated symptoms, including discomfort or dyspnea. It was also noted that it would be necessary to examine potential effects of mesenchymal stem cells given the number of factors that may have contributed to the efficacy or lack of efficacy of administering mesenchymal stem cells [Discussion ¶ 4].
Quantity of Experimentation Needed:
Enabling the full scope of treating “pain” would require a person of ordinary skill in the art to engage in massive disease-by-disease and pain-type research programs that would include such things as developing and validating disease models for any and all disease conditions that cause pain. Next, a person of ordinary skill would have to assess the effect mesenchymal stem cells exhibiting the selecting proteins and each of their effect on a variety of pain modalities, and then isolating the pain-reduction effect of these mesenchymal stem cells expressing these specific proteins independent of hyaluronic acid in order to evaluate the claimed composition’s effect on various pain types. Based on this, the experimentation would be extensive.
Conclusion:
Because claim 20, and its dependent claims, covers an extremely broad therapeutic scope that includes any form of pain, and the fact that the specification only provides one example directed at arthritis-induced pain in an animal model, and because the art indicates the unpredictable nature of administering mesenchymal stem cells, claim 20 is not considered enabled. Thus, claim 20 is not enabled.
Response to Argument
Applicant, in their response to the Non-Final Office Action, stated only that claim 20 had been amended canceling “preventing or” and “inflammatory disease” along with canceling claims 25 and 26 rendering the rejection moot.
Applicant’s amendments do not overcome the rejection under 35 U.S.C. §112(a) for lack of enablement. The enablement rejection was directed towards both preventing and treating inflammatory disease and also the recitation of preventing and/or treating “pain”. As the stated in the original rejection, there were no examples as to how Applicant’s claimed invention would treat “pain” given that pain can be caused by a number of factors that include chronic pain, neuropathic pain, pain related to trauma, e.g. compression injuries or fractured bones, and visceral or systemic pain [See Wand’s factor “Presence of Working Examples]. As stated above, Applicant has only provided a single example of pain reduction that involved induced arthritis in an animal model. There are no other examples provided for treating pain that results from non-arthritic inflammation. Because of this, the enablement rejection is maintained.
Based on Applicant’s amendments, Claims 20, 23, and 24 being 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 is withdrawn with respect to the generic phrase “preventing or treating inflammatory disease” being canceled.
Claims 25 and 26 were canceled by Applicant rendering rejection to these claims as moot.
Based on Applicant’s amendments, Claims 20, 23, and 24 being 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 is withdrawn with respect to the generic phrase “inflammatory disease” being canceled.
Claims 25 and 26 were canceled by Applicant rendering rejection to these claims as moot.
Based on Applicant’s amendments, Claims 20, 23, and 24 being 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 is withdrawn with respect to “TIMP1” or “BDNF” being canceled in the claim language.
Claims 25 and 26 were canceled by Applicant rendering rejection to these claims as moot.
Claim Rejections - 35 USC § 102
In light of Applicant’s amendments, the rejections to Claims 1-4, 7, 20, 23, 25, and 26 being rejected under 35 U.S.C. §102(a)(1) as being anticipated by Ferreira et al. [Mesenchymal stromal cell secretome: influencing therapeutic potential by cellular pre-conditioning, Front. Immunol., 2018] is withdrawn.
Claims 1-4, 7, and 25-26 have been canceled by Applicant rendering the rejection to these claims moot.
Claim Rejections - 35 USC § 103
In light of Applicant’s amendments, the rejections to Claims 5-6, 12-19, and 24 being rejected under 35 U.S.C. §103 as being unpatentable over Ferreira et al. [Mesenchymal stromal cell secretome: influencing therapeutic potential by cellular pre-conditioning, Front. Immunol., 2018], in view of Yin et al. [Label-free separation of mesenchymal stem cell subpopulations with distinct differentiation potencies and paracrine effects, Biomaterials, 2020], in view of Wilkins et al. [Human bone marrow-derived mesenchymal stem cells secrete brain-derived neurotrophic factor which promotes neuronal survival in vitro, Stem Cell Research, 2009], in view of Song et al. [Mesenchymal stem cell immunomodulation: mechanisms and therapeutic potential, Trends Pharmacol Sci., 2020], in view of Merck Millipore [Dulbecco’s Modified Eagle’s Medium (DMEM), 2015] is withdrawn.
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 20 and 23 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.
Claim 20 uses the generic term “pain” as it relates to treating inflammatory diseases or pain in a subject in need with a composition containing mesenchymal stem cells that have increased expression of certain proteins, i.e. PTX-3. The same generic scope of “pain” is present in each of the dependent claims, i.e. claim 23.
The specification provides antecedent basis for “pain” where the mesenchymal stem cells expressing PTX-3 are used in the treatment of inflammatory disease or pain [pg. 4 ¶ 1].
Applicant’s specification states “…is provided a method for obtaining mesenchymal stem cells with…pain reduction efficacy…” [Id.]. The specification also states that these particular mesenchymal stem cells have excellent pain reduction capacity [pg. 7 ¶ 4]. The specification further states that the specified mesenchymal stem cells can treat inflammatory pain, specifically arthritic pain [pg. 11 ¶ 2]. However, the specification only provides a working example that is directed to induced arthritis pain in an animal model [pg. 22-23]. The rats consisted of a control group, a test group, and a negative test group where they were administered lower doses of endothelial cells expressing low amounts of PTX-3 [Id.] with the test group being administered the mesenchymal stem cells with the increased levels of PTX-3 and 1% hyaluronic acid [Id]. The rats were then measured for inflammation and pain by determining the percentage of weight distribution on all four limbs over a set number of predetermined days. No other examples are provided. Additionally, Applicant’s specification does not disclose or provide examples of mesenchymal stem cells exhibiting the increased levels of claimed proteins treating other types of pain not associated with inflammatory pain, namely bone fractures, cluster headaches, compression injuries, etc. Furthermore, Weiss et al., discussing a randomized clinical trial involving administering mesenchymal stem cells in subjects diagnosed with COPD, disclosed there were no perceived reduction in pain or inflammation compared to the control group that did not receive a mesenchymal stem cell composition [Results ¶ 1]. Based on this, a person of ordinary skill would not understand what forms of pain can actually be treated based given the generic claim to treating “pain”. An Artisan would not understand what pain mechanisms would be capable of being reduced with the Applicant’s invention given that the specification only includes one example related to an animal model with induced arthritis pain.
Given the generic term “pain” as it relates to administering a composition containing mesenchymal stem cells for treating “pain”, and the absence of teaching what other pain can be treated other than pain associated with arthritic pain as discussed in Applicant’s specification, the Artisan would not understand Applicant to be in possession of the claimed mesenchymal stem cells that were capable of treating “pain”.
Response to Argument
Applicant bases their argument around the fact that “pain” is classified under the World Health Organizations disease code and that the specification demonstrates a “pain reducing effect” as stated in Applicant’s Example 4. Applicant further points out the originally filed specification describes the claimed method in such a way as to reasonably convey to one skilled in the art that the Applicant had possession of the claimed methods at the time of the filing in claims 20 and 23.
This argument is not persuasive.
Despite the World Health Organization categorizing “pain” under its disease coding framework, the specification provides only one working example directed to treatment of pain in the context of an induced arthritis animal model. This disclosure is narrowly directed to inflammatory pain associated with a specific pathological condition, i.e. arthritis. However, under broadest reasonable interpretation, the claim is not limited to only this example but includes treatment of “pain” broadly. A person of ordinary skill would interpret “pain” to include numerous distinct etiologies and mechanisms that include such things as neuropathic pain, acute pain, chronic pain, cancer-related pain, and post-surgical pain, etc. Because of this, Applicant has not shown possession of enhanced mesenchymal stem cells that are capable of treating pain beyond the examples provided in Applicant’s specification, i.e. inflammatory pain related to induced arthritis. It is this broad interpretation that includes all types of pain, and not just inflammatory pain associated with arthritis, that specification lacks written description under 35 U.S.C. §112(a). Because of this, claims 20 and 23 are newly rejected.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 12-17 are newly rejected under 35 U.S.C. §102(a)(1) as being anticipated by Kim et al. [Soluble PTX3 of human umbilical cord blood-derived mesenchymal stem cells attenuates hyperoxic lung injury by activating macrophage polarization in neonatal rat model, Stem Cells International, 2020].
Regarding claim 12, Kim et al. teaches a method for obtaining mesenchymal stem cells with improved pain reduction efficacy, the method comprsing: a step of stimulating mesenchymal stem cells exhibit increased expression of PTX-3 (pentraxin-related protein-3 [3.4 PTX3 augments the macrophage polarization effect by activating dectin-1 downstream signaling ¶ 1].
Regarding claim 13, Kim et al. teaches the method of claim 12, wherein the stimulating step includes exposing the mesenchymal stem cells to an inflammatory environment [3.4 PTX3 augments the macrophage polarization effect by activating dectin-1 downstream signaling ¶ 1].
Regarding claim 14, Kim et al. teaches the method of claim 13, wherein the step of exposing the mesenchymal stem cells to an inflammatory environment includes a co-culture with inflammation induced cells [3.4 PTX3 augments the macrophage polarization effect by activating dectin-1 downstream signaling ¶ 1].
Regarding claim 15, Kim et al. teaches the method of claim 14, wherein the inflammation-induced cells are cells in which inflammation has been induced by treatment with lipopolysaccharide (LPS), a mitogen, a chemokine, or a cytokine [Abstract].
Regarding claim 16, Kim et al. teaches the method of claim 15, wherein the cells are any one selected from the group consisting of somatic cells, germ cells, and a combination thereof [Abstract].
Regarding claim 17, Kim et al. teaches the method of claim 16, wherein the somatic cells are any one selected from the group consisting of muscle cells, hepatocytes, neurons, fibroblasts, epithelial cells, adipocytes, bone cells, white blood cells, lymphocytes, platelets or mucosal cells, and combination thereof [Abstract].
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.
Claims 18-20 and 23-24 are newly rejected under 35 U.S.C. §103 as being unpatentable over Kim et al. [Soluble PTX3 of human umbilical cord blood-derived mesenchymal stem cells attenuates hyperoxic lung injury by activating macrophage polarization in neonatal rat model, Stem Cells International, 2020], in view of Ferreira et al. [Mesenchymal stromal cell secretome: influencing therapeutic potential by cellular pre-conditioning, Front. Immunol., 2018], in view of Yin et al. [Label-free separation of mesenchymal stem cell subpopulations with distinct differentiation potencies and paracrine effects, Biomaterials, 2020], in view of Merck Millipore [Dulbecco’s Modified Eagle’s Medium (DMEM), 2015], in view of Wilkins et al. [Human bone marrow-derived mesenchymal stem cells secrete brain-derived neurotrophic factor which promotes neuronal survival in vitro, Stem Cell Research, 2009].
Examiner’s note: the cited reference, Kim et al., disclose mesenchymal stem cells overexpressing PTX-3 for reducing inflammation. Although the reference does not explicitly disclose treatment of pain, it is well established in the art that inflammatory processes produce pain through action of inflammatory mediators that sensitize certain pathways. A person of ordinary skill in the art would have reasonably expected that reducing inflammation using the disclosed PTX-3 expressing mesenchymal stem cells would result in a corresponding reduction in pain associated with inflammation.
Kim et al. teaches every element of claims 12-17. However, Kim et al. does not teach a method for preparing mesenchymal stem cells.
For claim 18, Ferreira et al. only discloses culturing isolated mesenchymal stem cells under hypoxic conditions of 2% to 5% [Table 2], and Ferreira et al. discloses subjecting isolated mesenchymal stem cells to inflammatory stimulation [The effect of pre-conditioning on MSC secretome ¶ 1]. However, Ferreira et al. does not teach isolating mesenchymal stem cells having a size of 10µm or lower. Ferreira et al. also does not teach a culture medium containing calcium. However Yin et al., discussing efficacious subpopulations of mesenchymal stem cells and their potential use in disease based on size, discloses separating mesenchymal stem cells based on size [Abstract]. More importantly, Yin et al. disclosed a method for separating spherical particles, e.g. mesenchymal stem cells, that ranged in size from 10µm to 25µm [3.1 Results ¶ 2].
With respect to the claim 18 limitation where the culture medium contained calcium, Wilkens et al., discussing the neuroprotective effect of mesenchymal stem cells secreting BDNF, discloses the use of DMEM for culturing mesenchymal stem cells [Results ¶ 1]. DMEM, also known as Dulbecco’s Modified Eagle Medium contains calcium at a concentration at approximately 1.8 mM as is the standard and well-known formulation that is routinely used in mammalian cell cultures. Therefore, there is a reasonable expectation of success that a person of ordinary skill would combine the teachings of Ferreira et al. with the additional teachings of Yin et al. that disclosed potential therapeutic uses for mesenchymal stem cells based on size with the additional teachings of Wilkins et al. that disclosed using DMEM, which is widely known in the art, as a culture medium for culturing mesenchymal stem cells and that this culture medium has a standard concentration of calcium at approximately 1.8 mM [Merck Millipore Formulation Table]. Based on this, it would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the claimed invention to modify the systems and methods of Ferreira et al. with the additional teachings of Yin et al. and Wilkins et al.
For claim 19 where the calcium is contained at a concentration of 1.5 to 3.8 mM, again, Wilkins et al. discloses the use of a calcium containing medium that is sold with a standard calcium concentration at around 1.8 mM as taught by Merck Millipore [Formulation].
For claims 20, 23, and 24 where the pain being treated is arthritis pain, Song et al. discloses using mesenchymal stem cells for the treatment of osteoarthritis where the clinical data showed a reduction in pain and synovial inflammation. Therefore, it would have been prima facie obvious to a person of ordinary skill in the art to modify the teachings of Ferreirra et al. that disclosed the using methods to influence therapeutic potential in mesenchymal stem cells through pre-conditioning that included exposure to inflammatory conditions, with the additional teachings of Song et al. where it disclosed the clinical studies that showed it was possible through administration of mesenchymal stem cells to reduce inflammation pain related to arthritis. Therefore, there is a reasonable expectation of success to modify the teachings of Ferreira et al. with the additional teachings of Song et al. to administer mesenchymal stem cells that have been pre-conditioned to express certain proteins and then use the mesenchymal stem cells that exhibit increased expression over mesenchymal stem cells that have not been exposed to inflammatory conditions for use in subjects suffering from arthritis related pain given that clinical trials had already shown the mesenchymal stem cells already exhibited a therapeutic effect to subjects suffering from arthritis type pain.
The Supreme court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable varition..103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions…
…the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) emphasis added.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton.").
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JOHN DAVID MOORE/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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