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
Currently, claims 44-45, 47-59, 61, 64-66 are pending in the instant application. Claims 1-43, 46, 60, 62-63 have been canceled. Claims 64-66 have been added and claims 55-57 and 64-66 are withdrawn. This action is written in response to applicant’s correspondence submitted 01/12/2026. All the amendments and arguments have been thoroughly reviewed but were found insufficient to place the instantly examined claims in condition for allowance. The following rejections are either newly presented, as necessitated by amendment, or are reiterated from the previous office action. Any rejections not reiterated in this action have been withdrawn as necessitated by applicant’s amendments to the claims. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. This action is FINAL.
Election/Restrictions
Newly submitted claims 64-66 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the recited RNA transcript, LINC00478 is structurally and functionally distinct from the elected RNA transcript. Applicant elected ZNF81 transcript in the response mailed 05/29/2025.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 64-66 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 44-45, 47-54 and 58-61 are under examination with respect to ZNF81 and claim 54 is under examination with respect to SEQ ID NO 17.
Drawings
The drawings are acceptable.
Withdrawn Rejections
The rejection of claims 52-54 under improper Markush grouping is withdrawn in view of the amendment to the claims.
The rejection of claims 44-45, 47-54 and 58-59 under 35 U.S.C. 102(a)(1) as being anticipated by Bersinger (Molecular Human Reproduction, 2008, vol 14, pp 475-484) is withdrawn in view of the amendment to the claims.
Maintained Rejections
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 44-45, 47-54 and 58-59 are rejected under 35 U.S.C. 101 because the claimed invention is directed to law of nature and abstract idea without significantly more. The claims recite a mental process and a natural phenomenon. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. This rejection was previously presented and has been rewritten to address the amendment to the claims.
The following inquiries are used to determine whether a claim is drawn to patent-eligible subject matter.
Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter? Yes, all of the claims are directed to a process.
Step 2A. Is the claim directed to a law of nature, a natural phenomenon or an abstract idea (judicially recognized exception) and does the claim recite additional elements that integrate the judicial exception into a practical application?
Yes, the claims are directed to law of nature/natural phenomenon. Claim 44-45 recites predicting outcome of embryo transfer based on determined amount of RNA transcript. Claim 58-59 recites determinizing quality of IVF embryo based on determined amount of RNA transcript. The recited relationship is a natural phenomenon that exists apart from any human action. This type of correlation is a consequence of natural processes.
The claims also recite the judicial exception of an abstract idea and particularly mental processes. Claim 44-45, 58-59 recites the abstract idea of a mental process. Claim 44-45 recites the step of “determining” an amount of at least one RNA transcript and “predicting” pregnancy outcome based on the determined amount of RNA transcript. Claim 58-60 recites the steps of “determining” the amount of at least one RNA transcript and “determining” the quality of IVF based on the determined amount of RNA transcript. Neither the specification or the claims set forth limiting definition for determining, selecting or predicting and the claims do not set forth how determining, selecting or predicting is accomplished. The broadest reasonable interpretation of the determining, selecting, and predicting step is a step that can be accomplished mentally by evaluating data and critical thinking process wherein one mentally reads information in a database or report regarding expression levels then draws a mental conclusion. Such “determining” “predicting” and “selecting” thereby encompasses process that may be performed mentally and this is an abstract idea.
Having determined that the claims recite a judicial exception, it is then determined whether the claims recite additional elements that integrate the judicial exception into a practical application.
The claims do not recite additional steps or elements that integrate the recited judicial exceptions into a practical application of the exception(s). For example, the claims do not practically apply the judicial exception by including one or more additional elements that the courts have stated integrate the exception into a practical application:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
An additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
An additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
An additional element effects a transformation or reduction of a particular article to a different state or thing; and
An additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological
environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
As mentioned above, a claim limitation can integrate a judicial exception by applying or using the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. When evaluating this consideration one must the following:
(i) the particularity or generality of the treatment or prophylaxis limitation;
(ii) whether the limitations have more than a nominal or insignificant relationship to the exception; and
(iii) whether the limitations are merely extra solution activity or field of use.
While the claims recite the step of contacting in vitro responder cells with extracellular vesicles isolated from an IVF embryo, these steps are not particular i.e., specifically identified so that it does not encompass all applications of the judicial exception. The claims recite a step of intrauterinally transferring IVP embryo into the female subject but this is a conditional step and only occurs if the IVF embryo is determined to be a good candidate. This step does not occur if the embryo is not a good candidate. Because this step is conditional it does not integrate the judicial exceptions.
In addition to the judicial exceptions the claims recite upregulated or downregulated level of RNA transcripts (claim 45, 47). Claim 48-51 recite responder cells. Claims 52-54 recite ZNF81 transcript. These additional steps/elements are not considered to integrate the judicial exception into a practical application because they merely add insignificant extra-solution activity (data gathering) to the judicial exception.
Step 2B - Does the claim recite additional elements that amount to significantly more than the judicial exception? No.
Herein the claims as a whole are not considered to recite any additional steps or elements that amount to significantly more than well-understood, routine, and conventional activities in the art and do not add something “significantly more” so as to render the claims patent-eligible. The step of obtaining EV from embryos and contacting the embryo to a responder cell and determine RNA transcript, including ZNF81 merely instructs a scientist to use well established, routine and conventional nucleic acid techniques to gather samples for diagnostic analysis. As address in the instant specification methods of expression analysis are well-known in the art (See para 40-41). The step of intrauterinally transferring at least one IVF embryo is a conditional step and only occurs if the embryo is selected and therefore encompasses a step of not performing intrauterninally transferring.
The step of determining RNA transcripts in responder cells constitutes a data gathering step required to apply the law of nature/natural phenomenon. It is acknowledged that the claims name particular biomarkers, ZNF81, whose level is to be determined however the claims do not require a particular, non-conventional primer or probe consisting of or comprising a specific nucleotide sequence or any other specific reagent that is used to accomplish such determining such that the claims would recite significantly more than the judicial exception. The targets to be detected are part of the judicial exception and thereby the naming of the targets does not add something “significantly more” to the recited judicial exceptions.
The additional steps and elements are recited at a high degree of generality and are all routine, well understood and conventional in the prior art. The recited steps and elements do not provide inventive concept necessary to render the claims patient eligible. There is no combination of elements in this step that distinguishes it from well-understood, routine and conventional data gathering activity engaged in by scientists prior to applicant’s invention and at the time the application was filed. Many cited prior art references in this record demonstrate that these techniques were conventional at the time of the invention. The prior art of Bersinger teaches contacting endometrial cells with embryo conditioned medium, isolating RNA from the endometrial cells and determining RNA transcripts. Thus the prior art and specification demonstrates it was routine, well-known and conventional in the art to determine expression of ZNF81 in responder cells. Dependent claims 45-47, 59, 62-63 further limit the recited judicial exception. Claim 47-51 further limit the responder cells. The dependent claims do not provide significantly more to the claims outside of the judicial exception as they encompass conventional techniques as described in the instant specification as noted above.
Response to Arguments
The response traverses the rejection on pages 9-11 of the remarks mailed 01/12/2026. The response asserts that the claims have been amended, claim 44 and 58 defines how an IVF embryo is determined to be good or not good and then intrauterinally transferring the IVF embryo into the female subject if the IVF embryo is determined to be good for transfer. The response asserts that in view of the amendment to the claims, the claims are directed to patent eligible subject matter because the actual, physical steps must be performed and the claim as a whole is not solely directed to mental steps. The response further asserts the claims are integrated into practical application through reciting intrauterine transfer of the IVF embryo into the female subject. This response has been thoroughly reviewed but not found persuasive.
While the claims do recite actual physical steps, these steps are routine, well known and conventional in the art as addressed in the rejection. With regard to the step of intrauterine transfer, this step does not integrate the judicial exception because this is a conditional step and only occurs if the IVF embryo is determined to be good for intrauterine transfer. If the IVF embryo is not determined to be good for transfer this step does not occur and there is no integration of the judicial exception. As such the amendment to the claims does not overcome the rejection of record.
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.
Claim 61 is 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. This is a new grounds of rejection applied to the newly amended claim 61.
Claim 61 recites the limitation “M potential IVF embryos” and "N IVF embryos" which renders the claim indefinite. While the claim recites M is an integer equal to or larger than two, the recitation of N IVF embryos is not defined in the claim. It is unclear what is encompassed by a N IVF embryo. Claim 61 requires “selecting the N IVF embryos…among M potential IVF embryos wherein N<M”. The claim does not define or describe N and it is unclear if N IVF embryos is the number of embryos or some other nomenclature for embryos. Additionally is unclear how selecting N IVF results in a largest downregulation of at least one RNA transcript. Because it is unclear what is encompassed by N IVF embryo, how this results in a largest downregulation RNA transcript, one of skill in the art cannot determine the metes and bounds of the claimed subject. Additionally the claim recites “largest” downregulation and “largest” upregulation, these recitations renders the claim vague and indefinite. It is unclear what is the largest when the claim does not require comparison to any other transcript and it is unclear what would be encompassed by largest.
Claim Rejections - 35 USC § 112(a)
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 44-45, 47-54 and 58-61 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of predicting increased Lakewood of pregnancy outcome comprising contacting RL95-2 cells with embryo conditioned medium treated cells and detecting down regulation of ZNF81 in RL95-2 cells embryo, does not reasonably provide enablement for contacting any responder cell with extracellular vesicles isolated from IVF embryo and determining any amount of RNA transcript to predict pregnancy outcome, embryo quality, or selecting any embryo for IVF procedure. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. This rejection was previously presented and has been rewritten to address the amendment to the claims.
Nature of the invention and breadth of the claims
The claimed methods are drawn to predicting outcome of an embryo transfer, predicting pregnancy outcome of an embryo transfer, determining quality of an IVF embryo, and selecting an embryo for IVF and comprise the analysis of RNA transcripts in a responder cell that has been contacted with extracellular vesicles isolated from IVF embryo or conditioned medium from the IVF embryo. Dependent claims include both up or down regulated transcripts. Additional claim requires ZNF81 transcript. The claims additionally require determining IVF embryo to be good for intrauterine transfer by a significant change in the amount of at least one RNA transcript and determining IVF embryo to not be good by no significant change in the amount of one RNA transcript relative to a reference level.
The claims generically encompass the analysis of any responder cell from any species for the detection of any RNA transcript to determine pregnancy outcome, quality of IVF embryo, and selection of embryo for IVF. The claims encompass any RNA transcript level to be determined, any change for quality of IVF embryo. The claims additionally require the largest downregulation of at least one RNA transcript of an IVF embryo to intrauterinally transfer.
The claims thus require knowledge of reliable and robust association between the presence of any RNA transcript in any responder cell in contact with EVs from an embryo or conditioned medium to determine pregnancy outcome, quality of IVF embryo, and selection of embryo for IVF, and intrauterinally transfer IVF embryos. Even with respect to the elected gene, the claims require knowledge of reliable and robust association between the presence of any amount of ZNF81 in any responder cell in contact with EVs from an embryo or conditioned medium to determine pregnancy outcome, quality of IVF embryo, and selection of embryo for IVF.
Direction provided by the specification and working example
The instant specification provides an example ZNF81 expression was determined in RL95-2 cells supplemented with human embryo conditioned media (see example 2). Relevant to the methods of the pending claims, the data of the specification (table 8) indicate that ZNF81 transcript is downregulated in RL95-2 cells supplemented with human embryo conditioned media in has a higher likihood change of pregnancy outcome (see table 8)
Relevant to the breadth of the claims, there is no analysis of embryo quality, selecting an embryo based on ZNF81 transcript levels in any responder cell contact with EV isolated from an IVF embryo. There is no analysis of any other RNA transcripts in responder cells contact with EV isolated. The is no analysis of any responder cell and RNA transcript amount other than RL95-2 cells or ZNF81. While there is analysis of RL95-2 with conditioned medium from the IVF embryo, there is no analysis of RNA amount including ZNF81 with any responder cell contacted with isolated EVs from embryos. The specification teaches analysis of EV induced ZNF81 downregulation in RL9-2 cells but does not provide any evidence that this predictably determine pregnancy outcome, embryo quality, or selection of an embryo for IVF. There is no analysis of RNA transcripts in responder cells that have been contacted with EV isolated from an IVF embryo to be transferred correlated with pregnancy outcome, embryo selection, or embryo quality. There is no analysis or identifying a largest downregulation or upregulation of at least one RNA transcript among potential IVF embryos and intrauterinally transferring at least one IVF embryo.
State of the art, level of skill in the art, and level of unpredictability
While the state of the art and level of skill in the art with regard to measuring RNA transcripts is high, the unpredictability in associating any particular transcript with a specific phenotype, or predicting embryo transfer, outcome, selection and quantity, as is encompassed by the claims, is even higher. The unpredictability is demonstrated by the related art and the instant specification.
Santos (Anim Reprod, 2025 22(3) e20250059, pp 1-18) teaches that although embryos can be developed in vitro, disruptions in their early dialogues can lead to poor pregnancy outcomes, altered gene expression patter and lower pregnancy rates (see pg. 2). Santos teaches culturing endometrial epithelia cells quickly lose normal cellular function due to differentiation and thereby reduce its biological similarity to in vivo cells (See table 1). Santos teaches 2D models offer simplicity and accessibility but the biological limitations necessitate development of more physiological relevant systems. Fernando (Reproductive and Developmental Medicine, 2024, 8:3, p 178-185) teaches embryo implantation rates for assisted reproduction remains low despite the transfer of good quality embryos. Fernando teaches changes in endometrial transcriptomics, proteomics, lipidomic, and even microbiota play important roles in embryo implantation. Poh (Proteomics, 2023, 23:2200107, pp1-28) teaches developmental and implantation phase differences between species must be considered when understanding the utility of human EVs. Poh teaches divergence from molecular differences in developmental competence of embryos in difference states. Poh further teaches various analyses have demonstrated that EV’s from human embryo spent media contain a very high abundance of co-isolated contaminates which complicates understanding of EVs specifically from human embryos. The post filing date art demonstrates the unpredictability of determining embryo quality among different species by determining transcription levels.
Quantity of experimentation required
A large and prohibitive amount of experimentation would be required to make and use the claimed invention. Given that the claims generically encompass any subject organisms, any transcript and any responder cell, one would have to perform large case: control studies, and validation of any results, to determine which transcripts in any subject organisms and which transcripts are up and down regulated in a genus of responder cells and the transcript amount is reliably and robustly associated with outcome of pregnancy, embryo quality and embryo selection. Even for the elected transcript, ZNF81, disclosed in the specification as consistent, given the lack of guidance with respect to amount of transcription in a representative number of responder cells contacted with EVs or media, one would have to perform an analysis to see if a representative number of responder cells have up or down regulated ZNF81 and include a robust and reliable the association of this transcript with pregnancy outcome, embryo quality and selection of embryo.
Conclusion
Taking into consideration the factors outlined above, including the nature of the invention and breadth of the claims, the state of the art, the level of skill in the art and its high level of unpredictability, and the particular guidance in the specification including the examples, it is the conclusion that an undue amount of experimentation would be required to make and use the invention as claimed.
Response to Arguments
The response traverses the rejection on pages 11-13 of the remarks mailed 01/12/2026. The response asserts that example 4 shows that EVs isolated from an IVF embryo or conditioned medium from an IVF embryo contain different RNA transcripts that EVs isolated from cells of non-reproductive origin. The response asserts that example 4 shows that transcriptomic changes induced by EVs from IVF embryos are not random but a purposeful process specific to a biological phenomenon, maternal communication. The response further asserts that the EVs derived from IVF embryos are able to induce an environment favorable for implantation which is unique to EVs derived from IVF embryos compared to EVs from non-reproductive source. The response asserts example 5 compares the RNA transcript changes in reporter cells supplemented with EVs with IVG embryos of good quality as compared to reporter cells with EVs derived from IVF embryos of poor quality. 4 genes were significantly upregulated and 11 genes were significantly downregulated. The response asserts example 3 shows significant change in RNA transcript in reporter cells treated with EVs derived from IVFs where a change could be used to predict outcome of transfer and pregnancy. The response asserts that the specification shows not only endometrial RL95-2 cells but bovine oviductal epithelial cells as reporter cells.
This response has been thoroughly reviewed but not found persuasive. The post filing art demonstrates the unpredictability of determining expression of transcripts in embryos and successful implantation of selected embryos. The specification demonstrates transcription changes of RL95-2 cells from HEK293 cells and JAR cell derived from EV. The example demonstrates there was very limited variance between untreated RLP95-2 cells and cells treated with HEK293 EVs. Example 4 demonstrates the difference between JAR Evs and HEK293 cell derived EVs but this does not demonstrate that expression changes are correlated to determining IVF embryos good for transfer, this only demonstrates the expression changes of RPL95-2 cells treated with EVs, there is no analysis of selected embryos good for transfer. As addressed in the specification the differences in expression profiles could aid in interpreting the observed EV induced effects of RL95-2 transcriptome and analyzed a possible environment favorable for implantation in the endometrium but there is no suggestion of selecting good embryos based on transcription levels and implanting the selected embryos.
The response points to example 5, however example 5 proposed to identify a role between embryo-maternal dialogues. This example analyzes BOEs and the effect on embryo quality. Example 5 demonstrates 4 upregulated genes and 11 downregulated genes of good quality embryo derived EVs supplemented BOEC. The genes that were asserted to be associated with good quality embryos are demonstrated in table 14, however ZNF81 was not demonstrated to be associated with good quality embryos, which demonstrates that not all cells or species are correlative with transcription changes to determine good quality embryos for transfer.
The response asserts example 3 shows significant change in RNA transcript in reporter cells treated with EVs derived from IVFs where a change could be used to predict outcome of transfer and pregnancy. As addressed above, the post filing date art demonstrates the unpredictability of selecting an embryo based on transcription changes for implantation. The specification while it may suggest a change could be used, this does not demonstrate a predictable association of a change in transcription level and selecting a embryo for transplantation. For these reasons and reasons of record the rejection is maintained.
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 44-54, 58-59, and 61 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Godakumara (J Extracell Viscles, 2019, Apr 23(suppl 1), PTO2.04)
The claims are enabled to the extent of the specification in order to provide compact prosecution Godakumar is provided as it teaches the positive active steps of the claims.
Godakumar teaches culturing human embryos, collecting conditioned media and isolating extracellular vesicles. Godakumar teaches a monolayer of RL95-2 cells was treated with isolated EVs (claim 49-51, reproductive, endometrial, and RL95-2 cells). Godakumar teaches gene expression of ZNF81 and control genes in RL95-2 cells were measured for quantification (see methods) (claims 52-54, RNA transcript comprising exonic region, SEQ ID NO 17). Godakumar teaches EVs derived from normal blastocytes and day 3 embryos undergo normal development significantly downregulate ZNF81 expression in endometrial cells compared to untreated controls (reference level) (claim 47). Godakumar teaches RL95-2 cells respond in different manners to EV from normal and degraded human embryos and can facilitate development of biomarkers for differentiating viable and degraded embryos at early stages after IVF (see summary). Thus, Godakumar teaches downregulated transcripts of ZNF81 predict pregnancy outcome, embryo quality and selecting embryo as Godamur teaches RNA expression levels in embryo conditioned endometrial cells and EV contacted cells with normal blastocytes and embryos that undergo normal development which inherently include IVF good for transfer, quality of IVF embryo, and selection of embryo.
With regard to claim 61, the step of selecting at least one IVF embryo is a mental step and does not require performing experimental or clinical steps or any other steps that are transformative. The specification does not provide a limiting definition for how “selecting” is to be accomplished. Thereby “selecting” is not tied to a machine and is not transformative since “selecting” may be performed entirely in one' s mind or may involve only verbal or written communication. Thus claims 61-63 are not considered to distinguish over the prior art.
Response to Arguments
The response traverses the rejection and asserts that the Godakumara reference was published April 23, 2019 and the present US patent application was filed with a priority date of Sept 18, 2019. The response asserts the grace period for the US patent application extend to Sept 18, 2018 and Godakumara reference is less than one year before the effective filing date of the patent application. The response asserts that the exception under 35 USC 102(b)(1)(A) applies and Godakumara reference should not be considered prior art. This response has been reviewed but not found persuasive. Godakumara is by others that are not listed as inventors on the instant application. Specifically Freddy Lattekivi and Ulle Jaakma are authors on the Godakumara et al reference but are not inventors on the instant application. As such the exception does not apply to the reference of Godakumara. For these reasons and reasons of record this rejection is maintained.
Conclusion
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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/SARAE L BAUSCH/ Primary Examiner, Art Unit 1699
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