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 .
DETAILED ACTION
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 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.
Election/Restrictions
Applicant’s election without traverse of Invention II, claims 9, 10, 12-19 and 30-32 in the reply filed on Jun. 23, 2026 is acknowledged.
Claims 1-4, 6, 9, 10, 12-19, 22-25, 27 and 30-32 remain pending in the current application, claims 1-4, 6, 22-25, and 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
The requirement for the restriction of Inventions I-III is still deemed proper and is therefore made FINAL.
Claims 9, 10, 12-19 and 30-32 have been considered on the merits.
Status of the Claims
Claims 1-4, 6, 9, 10, 12-19, 22-25, 27 and 30-32 are currently pending.
Claims 1-4, 6, 22-25, and 27 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 5, 7-8, 11, 20-21, 26, 28-29 and 34-43 are cancelled.
Claims 9, 10, 12-19 and 30-32 have been considered on the merits.
Drawings
The disclosure is objected to because of the following informalities:
The drawings are objected to because of the following informalities: there is description of color in the specification in Fig. 7D in 0091 (red spike) and the color cannot be distinguished since the figures are in black and white.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112 (b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9, 10, 12-19 and 30-32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites:
“Rolipram (4-(3-(Cyclopentyloxy)-4-methoxyphenyl)pyrrolidin-2-one), a derivative thereof, or a combination thereof;
Forskolin (3R,4aR,5S,6S,6aS,10S,1OaR, lObS)-3-Ethenyl-6,10, lOb-trihydroxy- 3,4a,7,7,10a-pentamethyl-1-oxododecahydro-1H-naphtho[2,1-b]pyran-5-yl acetate), a derivative thereof, or a combination thereof;
CHIR99021 (6-((2-((4-(2,4-Dichlorophenyl)-5-(4-methyl-1H-imidazol-2-yl)pyrimidin-2- yl)amino)ethyl)amino)nicotinonitrile)), a derivative thereof, or a combination thereof;
SB431542 (4-[4-(2H-1,3-Benzodioxol-5-yl)-5-(pyridin-2-yl)-1H-imidazol-2- yl]benzamide), a derivative thereof, or a combination thereof;
Valproic acid (2-propylpentanoic acid), a derivative thereof, or a combination thereof;
RG108 (N-Phthalyl-L-tryptophan), a derivative thereof, or a combination thereof;
Parnate (trans-2-phenylcyclopropylamine), a derivative thereof, or a combination thereof;
Resveratrol (5-[(E)-2-(4-Hydroxyphenyl)ethen-1-yl]benzene-1,3-diol), a derivative thereof, or a combination thereof;
Retinoic acid ((2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona- 2,4,6,8-tetraenoic acid), a derivative thereof, or a combination thereof; and
a Neuregulin protein, a derivative thereof, or a combination thereof”.
The phrase “a derivative thereof or a combination thereof” with respect to each compound is unclear. It is unclear what modifications of the various compounds would be encompassed in the derivatives. Does it include any modification, resulting in any structure or does it include only those modifications that retain the activity of the original compound? What activity would have to be retained? Thus, it is unclear what modifications and derivatives are encompassed by the claimed derivatives.
In claim 15, lines 2-3, the phrase “wherein the method is used to treat or prevent a cardiovascular disease in a subject”, renders the claim and its dependents indefinite, since it is unclear how the method is being used to achieve this purpose. The claim does not set forth any steps involved in using the method to treat or prevent a cardiovascular disease in a subject, it is unclear what applicant is intending to encompass by “using the method”. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. It is not clear from the claim how the method is being used.
In claim 15, lines 3, the phrase “in a subject”, renders the claim and its dependents indefinite, since it is unclear whether this is a second subject or is meant to refer to subject being administered the composition of claim 9. For the sake of compact prosecution the phrase will be interpreted to mean “in the subject”.
In claim 18, line 2, the phrase “wherein the method is used to treat the cardiovascular disease”, renders the claim and its dependents indefinite, since it is unclear how the method is being used to achieve this purpose. The claim does not set forth any steps involved in using the method to treat a cardiovascular disease in a subject, it is unclear what applicant is intending to encompass by “using the method”. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. It is not clear from the claim how the method is being used.
In claim 30, lines 1-3, the phrase “wherein the method is used to generate a cardiac tissue”, renders the claim and its dependents indefinite, since it is unclear how the method is being used to achieve this purpose. The claim does not set forth any steps involved in using the method to generate a cardiac tissue”, it is unclear what applicant is intending to encompass by “using the method”. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. It is not clear from the claim how the method is being used.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under USC 112 for the reasons set forth above.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (a) written description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9, 10, 12-19 and 30-32 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 claims 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 inventors, at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitations of:
“Rolipram (4-(3-(Cyclopentyloxy)-4-methoxyphenyl)pyrrolidin-2-one), a derivative thereof, or a combination thereof;
Forskolin (3R,4aR,5S,6S,6aS,10S,1OaR, lObS)-3-Ethenyl-6,10, lOb-trihydroxy- 3,4a,7,7,10a-pentamethyl-1-oxododecahydro-1H-naphtho[2,1-b]pyran-5-yl acetate), a derivative thereof, or a combination thereof;
CHIR99021 (6-((2-((4-(2,4-Dichlorophenyl)-5-(4-methyl-1H-imidazol-2-yl)pyrimidin-2- yl)amino)ethyl)amino)nicotinonitrile)), a derivative thereof, or a combination thereof;
SB431542 (4-[4-(2H-1,3-Benzodioxol-5-yl)-5-(pyridin-2-yl)-1H-imidazol-2- yl]benzamide), a derivative thereof, or a combination thereof;
Valproic acid (2-propylpentanoic acid), a derivative thereof, or a combination thereof;
RG108 (N-Phthalyl-L-tryptophan), a derivative thereof, or a combination thereof;
Parnate (trans-2-phenylcyclopropylamine), a derivative thereof, or a combination thereof;
Resveratrol (5-[(E)-2-(4-Hydroxyphenyl)ethen-1-yl]benzene-1,3-diol), a derivative thereof, or a combination thereof;
Retinoic acid ((2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona- 2,4,6,8-tetraenoic acid), a derivative thereof, or a combination thereof; and
a Neuregulin protein, a derivative thereof, or a combination thereof”.
However, the specification provides no description what a “derivative thereof” would be for each of the claimed compounds. The specification states that “a composition that includes the following compounds: Rolipram, a derivative thereof, or a combination thereof; Forskolin, a derivative thereof, or a combination thereof; CHIR99021, a derivative thereof, or a combination thereof; SB431542, a derivative thereof, or a combination thereof; Valproic acid, a derivative thereof, or a combination thereof; RG108, a derivative thereof, or a combination thereof; Parnate, a derivative thereof, or a combination thereof; Resveratrol, a derivative thereof, or a combination thereof; Retinoic acid, a derivative thereof, or a combination thereof; and a Neuregulin protein, a derivative thereof” (0003 of published application). A similar statement is made in para. 0022 of published application. Additionally, the specification discloses that derivatives of the compounds,
“include one or more moieties derivatives of one or more compounds. In some embodiments, the one or more derivatives include one or more moieties derivatized with one or more functional groups. In some embodiments, the one or more functional groups include, without limitation, alkanes, alkenes, ethers, alkynes, alkoxyls, aldehydes, carboxyls, hydroxyls, hydrogens, sulfurs, phenyls, cyclic rings, aromatic rings, heterocyclic rings, linkers, methyl groups, hydrogen groups, tracing agents, derivatives thereof, and combinations thereof.” (0023 of published application)
The specification describes derivatives of a Neuregulin protein to include proteins that share at least 60%, 80%, 90% or 95% sequence identity with one or more of Neuregulin-1, Neuregulin-2, Neuregulin-3, and Neuregulin-4 (0024 of published application). These general descriptions do not aid in providing specific structures that would constitute functional derivatives of the compounds used in the claimed method of generating differentiated cardiac cell by exposing cardiac progenitor cells to a composition containing the compounds and/or their derivatives.
The specification does not disclose structural guidance (specific moieties for the each of the claimed compounds or specific sequences, minimum lengths for Neuregulin) and functional assays defining how to identify, produce, and confirm the claimed derivatives activities. The specification and the claims do not provide any guidance on how to select moieties for each compound that would be functional and does not provide guidance on which amino acid segments of the Neuregulin would be a functional derivative. There is no description in the specification of the structural features necessary for a derivative, no description of functional assays that could define such derivatives, no correlation between structure and function of the derivatives, and no working examples of any of any derivative of the claimed compounds.
The purpose of the written description requirement is to ensure that the specification had possession, as of the filing date of the application, of the specific subject matter claimed. A patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention. The specification lacks any structural description of the claimed derivatives of the different compounds and does not provide any examples of such derivatives. Accordingly, the specification fails to provide adequate written description for the listed derivatives of the claimed compounds, and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed had possession of the entire scope of the claimed invention. Thus, the written description requirement has not been satisfied.
Claim Rejections - 35 USC § 112 (a) scope of enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9, 10, 12-19 and 30-32 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 an in vitro method of generating cells that resemble cardiac Purkinje cells, said method comprising
exposing cardiac progenitor cells to a composition comprising the following compounds:
2 µM Rolipram (4-(3-(Cyclopentyloxy)-4-methoxyphenyl)pyrrolidin-2-one);
10 µM Forskolin (3R,4aR,5S,6S,6aS,10S,1OaR, lObS)-3-Ethenyl-6,10,10b-trihydroxy- 3,4a,7,7,10a-pentamethyl-1-oxododecahydro-lH-naphtho[2,1-b]pyran-5-yl acetate);
4 µM CHIR99021 (6-((2-((4-(2,4-Dichlorophenyl)-5-(4-methyl-lH-imidazol-2-yl)pyrimidin-2- yl)amino)ethyl)amino)nicotinonitrile));
2 µM SB431542 (4-[4-(2H-1,3-Benzodioxol-5-yl)-5-(pyridin-2-yl)-1H-imidazol-2- yl]benzamide);
2 µM Valproic acid (2-propylpentanoic acid);
2 µM RG108 (N-Phthalyl-L-tryptophan);
2 µM Parnate (trans-2-phenylcyclopropylamine);
10 µM Resveratrol (5-[(E)-2-(4-Hydroxyphenyl)ethen-1-yl]benzene-1,3-diol);
1 µM Retinoic acid ((2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona- 2,4,6,8-tetraenoic acid);
10 µM of a Neuregulin protein; and
10 µM Epinephrin (4-[(lR)-1-hydroxy-2-(methylamino )ethyl]benzene-1,2-diol);
wherein the differentiated cardiac cells that resemble cardiac Purkinje cells are genetically, functionally, morphologically, and electrophysiologically similar to native cardiac Purkinje cells after seven days of exposure to the composition; and wherein the cells are cultured on fibrin matrix.
The Specification does not reasonably provide enablement for the generation of all types of cardiac cells with all potential concentrations of the claimed compounds for any period of exposure time. Additionally, the specification does not provide support for an in vivo method of exposing in a subject where the exposing comprises administering the composition to a subject where the method is used to treat or prevent a cardiovascular disease in a subject as recited in claims 13 and 15-19.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, the enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method of generating differentiated cardiac cells in vivo and in vitro by exposing cardiac progenitor cells to a composition containing ten different compounds (Rolipram, Forskolin, CHIR99021, SB431542, Valproic acid (VPA), RG108, Parnate, Resveratrol, Retinoic acid, and Neuregulin), their derivatives and/or combination thereof at any concentration for any length of time.
Additionally, the claims 13 and 15-19 are directed to treating and preventing a cardiovascular disease in a subject. Claim 16 further limits the method to locally administering the composition to the cardiac tissue of the subject. Claim 17 further limits the method to cardiac tissue to being near or at the ventricular myocardium. Claim 18 limits the subject to one who is suffering from a cardiovascular disease and the method is used to treat the cardiovascular disease. Claim 19 further limits the cardiovascular disease to heart failure, arrhythmia or a combinations thereof.
Thus, the claims taken together with the specification imply that any kind of differentiated cardiac cell (fibroblast, endothelial, cardiac muscle, pacemaker, etc.), can be generated by exposing cardiac progenitor cells to the composition of claim 9 where the compounds are at any concentration and the exposing is for any length of time. Additionally, the claims taken together with the specification imply that any kind of cardiovascular disease including heart failure and arrhythmia can be treated or prevented by administering the composition of claim 9 where the compounds are at any concentration and the exposing is for any length of time. Further any form of administering of the composition is encompassed.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The prior art in general teaches the complexity of differentiating cardiac progenitor cells into particular cardiac cell types. For instance, Hou et al. (Stem Cell Research, 2022) reports that the in vitro differentiation of human pluripotent stem cells into sinoatrial node-like cells (a differentiated cardiac cell) requires an optimized concentration of specific small molecules in the medium and treatment timing (abstract and introduction). Tracy et al. (Cardiovascular Engineering and Technology, 2020) reports developing a multi-step process using transcription factors to form cardiac Purkinje cells from hADMSCs (human adipogenic mesenchymal stem cells) (abstract, pg. 588 last para. to pg. 589 para. 2, and Fig. 1). Thus, as the state of the art stands, the method would be unpredictable depending on many factors including the specific cell type being generated, the concentration of the compounds the cells are being exposed to, and the timing of the exposure.
Inventions targeted for the treatment and prevention of cardiovascular disease bear a responsibility to provide supporting evidence because of the unpredictability in biological responses to therapeutic treatments. In support, Hong (Frontiers in Drug Discovery, 2022) reports the need for more predictive preclinical models for testing new cardiovascular drugs and that mouse models often fail to translate to humans (pg. 5 Col.1 last para. to Col. 2 para. 2). Hong notes the need for new screening platforms to effectively screen for new therapeutic agents (pg. 6 Col. 1 para. 3). In further support, Klose et al. (The FASEB Journal, 2019) (ref. of record) reports that there is no viable therapeutic option for the effective and sustained reversal of cardiac failure other than heart transplantation and mechanical circulatory assist devices (abstract). Klose further states that there are safety issues and obstacles that need to be overcome before clinical translation of therapeutic technologies especially relating to cardiac reprogramming of cells (abstract and pg. 66 Col. 1 para. 3-5). Thus, as the state of the art stands, treatment and prevention of cardiovascular disease is highly unpredictable.
(5) The relative skill of those in the art:
The relative skill of those in the art is high.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The instant specification provides working examples and guidance for the use of the instantly claimed method for generating cells that resemble cardiac Purkinje cells which are genetically, functionally, morphologically, and electrophysiologically similar to native cardiac Purkinje cells after seven days of exposure a composition containing 2 µM Rolipram, 10 µM Forskolin, 4 µM CHIR99021, 2 µM SB431542, 2 µM Valproic acid 2 µM, 2 µM RG108, 2 µM Parnate 10 µM Resveratrol, 1 µM Retinoic acid, 10 µM Neuregulin, and 10 µM Epinephrin and where the cells are grown on a fibrin matrix (Examples 1.2-1.5, 0067-0068, 0073 and Table 1).
However, the specification does not provide any guidance for the use of the instantly claimed method for generating all types of cardiac cells (fibroblast, endothelial, cardiac muscle, pacemaker, etc.) by exposing cardiac progenitor cells to the composition of claim 9 where the compounds are at any concentration and the exposing is for any length of time. The applicants have provided no additional data demonstrating the claimed method can generate other cardiac cells, the claimed method can generate cardiac cells with other concentrations of the claimed compounds and the claimed method can generate cardiac cells when the exposure to the composition is a different lengths of time. There is no specific guidance what concentrations the compounds would need to be at to generate other cardiac cell types or for what length of time.
Therefore, there is no conclusive evidence in the instant disclosure to indicate that the instantly claimed method can be used to generate all types of cardiac cells by exposing cardiac progenitor cells to the composition of claim 9 where the compounds are at any concentration and the exposing is for any length of time.
The instant specification only provides generalized guidance for the use of the instantly claimed method for the therapeutic application of cardiac Purkinje-like cells formed by disclosed methods and the disclosed compositions to treat or prevent cardiovascular disease (0035-0042). The specification does not provide any working examples for the treatment or prevention of a cardiac disease in a subject by administering the composition recited in claim 9 or for generating cardiac cells in vivo in a subject.
The applicants have provided no data demonstrating the claimed method would work for the in vivo generation of cardiac cells in a subject or for the treatment or prevention of a cardiac disease in a subject. There is no specific guidance how to administer the composition, what particular concentrations the compounds should be used, what cardiac cell types are being generated in vivo, for what length of time the exposure is or the dosage of the composition. In the instant case, the applicants have provided no accepted, conventional models for cardiovascular disease treatment. The high degree of unpredictability associated with the claimed method underscores the need to provide teachings in the specification that would provide the skilled artisan with specific treatment regimens that achieve a therapeutic benefit by in vivo or ex vivo therapy with regard to treatment of cardiovascular disease at least in a mouse model or cell model.
Additionally, “prevention” provides the expectation that the disorder/condition does not occur in response to a challenge or initiating event. While there is no requirement that prevention must be absolute in all cases, there is a reasonable expectation that some element of prevention can be shown. The standard for such is extremely high, and it is expected that the showing will be actual rather than implied, prophetic, or with a model. The standard of enablement is higher for such inventions because effective preventions of disease conditions are relatively rare and may even be unbelievable in the absence of strong supporting evidence.
Further, the burden of enabling the prevention of a disease is greater than that of enabling a treatment method due to the need to screen the subjects susceptible to the respective condition and the difficulty of proof that the administration of the drug was the agent that acted to prevent the condition. The specification does not provide guidance as to how one skilled in the art would go about screening those patients susceptible to cardiovascular disease, nor is guidance provided as to a specific protocol to be utilized in order to prove the efficacy of the presently claimed methods in preventing cardiovascular disease.
Therefore, there is no conclusive evidence in the instant disclosure to indicate that the instantly claimed method can be used to generate all types of cardiac cells in vivo by exposing cardiac progenitor cells to the composition of claim 9 where the compounds are at any concentration and the exposing is for any length of time and for the treatment or prevention of a cardiac disease in a subject by administering the composition recited in claim 9.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed above and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to use the claimed invention within the broad scope as instantly claimed.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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