DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on October 6, 2025 has been reviewed by the examiner and entered of record in the file. Claims 1, 27, 28 and 31 are amended. Claims 4 and 8 are canceled.
3. Claims 1-7, 10-15, 21, 22 and 25-33 are present in the application, and are under examination in this office action.
Previous Claim Rejections - 35 USC § 112
4. Claims 27-32 were previously rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as lacking antecedent basis.
In view of Applicant’s amendment to delete the recitation of “diagnosing is performed” in claims 27, 28, and 31, the previous indefiniteness rejection is withdrawn.
New Claim Rejections - 35 USC § 112(b)
5. 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.
6. Claims 1-3, 5-7, 10-15, 21, 22 and 25-33 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.
7. Claim 1 is indefinite in the following aspects:
(a) Claim 1 is drawn to a method for preventing and/or reducing ischemia damage in a subject, comprising administering a compound, or salt thereof, to the subject, wherein the compound is:
“
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or a salt thereof,”
which renders the claim indefinite because it is not clear if the statins listed in the right column of the table, i.e., under “Further related statins” are part of the claimed invention, or if they are exemplary.
In view of a broadest reasonable interpretation of the claim, the statins named in the right column of the table under the column labeled “Further related statins” are construed to be part of the claimed invention.
(b) In the list in the right column of the table, in the first row, lines 2-3, a comma is missing after “4-hydroxy atorvastatin”, and in line 4, a comma is missing after “2-hydroxy atorvastatin”. And, a period is present in line 7 after the term “lactone”.
In the list in the right column of the table, in the second row, line 3, “simvastatin acid terivastatin” is confusing because “simvastatin acid” is also known as “Tenivastatin.” Therefore, the recitation of “simvastatin acid terivastatin” is confusing and redundant. It is also noted that “terivastatin” as presently claimed is misspelled, i.e., the correct spelling is Tenivastatin.
8. Claims 2, 3, 5-7, 10-15, 21, 22 and 25-33 are rejected as being dependent upon and including all of the limitations of claim 1 that are rejected, above.
9. Claim 6 is rejected as being indefinite in the following aspects:
(a) Claim 6 is drawn to a method for preventing and/or reducing ischemia damage in a subject, comprising administering a compound, or salt thereof, to the subject, wherein the compound is:
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,
which renders the claim indefinite because it is not clear if the statins listed in the right column of the table, i.e., under “Further related statins” are part of the claimed invention, or if they are exemplary.
In view of a broadest reasonable interpretation of the claim, the statins named in the right column of the table under the column labeled “Further related statins” are construed to be part of the claimed invention.
(b) In the list in the right column of the table, in the first row, lines 2-3, a comma is missing after “4-hydroxy atorvastatin”, and in line 4, a comma is missing after “2-hydroxy atorvastatin”. And, a period is present in line 7 after the term “lactone”.
10. Claim 26 is rejected as being indefinite in the following aspects:
(a) Claim 26 is drawn to a method for preventing and/or reducing ischemia damage in a subject, comprising administering a compound, or salt thereof, to the subject, wherein the compound is:
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,
which renders the claim indefinite because it is not clear if the statins listed in the right column of the table, i.e., under “Further related statins” are part of the claimed invention, or if they are exemplary.
In view of a broadest reasonable interpretation of the claim, the statins named in the right column of the table under the column labeled “Further related statins” are construed to be part of the claimed invention.
(b) In the list in the right column of the table, in the second row, line 3, “simvastatin acid terivastatin” is confusing because “simvastatin acid” is also known as “Tenivastatin.” Therefore, the recitation of “simvastatin acid terivastatin” is confusing and redundant. It is also noted that “terivastatin” as presently claimed is misspelled, i.e., the correct spelling is Tenivastatin.
11. Claim 28 is unclear regarding whether the claim is directed to an additional step of treating the subject or a method of screening the subject by an unspecified criterion, i.e., it is not clear from the claim itself how the subject is assessed for recognition of a symptom or what said “recognition” entails. And, the meaning of the recitation of “symptom” is unclear to one of skill in the art, i.e., does any symptom correlate to a diagnosis? Therefore, one skilled in the art would not know how to perform the recited method.
12. Claim 29 is indefinite regarding the recitation of “discomfort in other areas of the body” because it is not clear what is embraced by “other areas of the upper body.”
13. Claims 29 and 30 are rejected as being dependent upon and including all of the limitations of claim 28.
14. Claim 31 is confusing for reciting the limitation of diagnosing ischemia “by assessing a marker of ischemia,” because it is not clear from the claim itself how the subject is diagnosed/ assessed, i.e., what assay and criterion (binding/ sensitivity/ correlation, etc) are used for the step of “assessing a marker,” and it is also not clear what marker is intended.
Clarification is requested.
15. Claim 32 is rejected as being dependent upon and including all of the limitations of claim 31.
New Claim Rejections - 35 USC § 112(a)
16. 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.
17. Claims 1-3, 5-7, 10-15, 21, 22 and 25-33 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 administering atorvastatin or simvastatin to a subject in need thereof for mitigating ischemic damage due to an ischemia caused by myocardial infarction wherein the ischemia is produced in the heart, is not enabled for a method of preventing or reducing any/ all types of ischemia damage wherein the ischemia is produced in any tissue or organ selected from kidney, intestines, pancreas, liver, lung, skeletal muscle, and combinations thereof, as presently recited. 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.
18. The standard for determining whether the Specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? As recognized by the court in In re Wands, 858 F.2d 731 (Fed. Cir. 1988), that is still the standard to be applied, determined by consideration of the Wands factors (MPEP 2164.01(A)); namely, nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered, with the most relevant factors discussed below.
19. Nature of the Invention: As stated in MPEP 2164.05(a), “[t]he initial inquiry” for determining whether the Specification is enabling “is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains.”
20. In the instant case, the claimed invention pertains to a method of preventing and/or reducing ischemia damage, comprising administering a compound or salt thereof to said subject by intravenous administration, not more than 60 minutes after the onset of ischemia, wherein the compound is:
atorvastatin, beta-oxidized atorvastatin, unsaturated beta-oxidized atorvastatin, beta-oxidized hydroxy atorvastatin, 4-hydroxy atorvastatin, para-hydroxy atorvastatin acid, atorvastatin lactone, atorvastatin acyl glucuronide, 2-hydroxy atorvastatin, ortho-hydroxy atorvastatin acid, 4-hydroxy atorvastatin acyl glucuronide, 4-hydroxy atorvastatin lactone, and 2-hydroxy atorvastatin lactone, or
simvastatin, 3’,5’-dihydrodiolsimvastatin, 6’beta-hydroxymethylsimvastatin, 6’beta-carboxysimvastatin, 6’-beta-hydroxysimvastatin, 6’-exomethylenesimvastatin, simvastatin acid (tenivastatin), simvastatin acid glucuronide and 3’hydroxysimvastatin,
or a salt thereof, and wherein the ischemia damage is due to an ischemia caused by:
atherosclerosis, thrombosis, bypass surgery, organ transplantation, ST-elevated myocardial infarction, non-ST-elevated myocardial infarction, or a combination of two or more of these, and
wherein the ischemia is produced in a tissue or organ selected from the group consisting of heart, kidney, intestine, pancreas, liver, lung, skeletal muscle, and combinations thereof.
21. The State of the Prior Art and the Relative Skill of those in the Art: As stated in MPEP 2164.05(a), “[t]he state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains” and, as stated in MPEP 2164.05(b), “[t]he relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed.”
As discussed above, the instantly claimed invention pertains a method of preventing or treating ischemia damage produced in a tissue or organ selected from the group consisting of heart, kidney, intestine, pancreas, liver, lung, skeletal muscle, and combinations thereof, comprising administering a compound selected from atorvastatin, beta-oxidized atorvastatin, unsaturated beta-oxidized atorvastatin, beta-oxidized hydroxy atorvastatin, 4-hydroxy atorvastatin, para-hydroxy atorvastatin acid, atorvastatin lactone, atorvastatin acyl glucuronide, 2-hydroxy atorvastatin, ortho-hydroxy atorvastatin acid, 4-hydroxy atorvastatin acyl glucuronide, 4-hydroxy atorvastatin lactone, and 2-hydroxy atorvastatin lactone, or
simvastatin, 3’,5’-dihydrodiolsimvastatin, 6’beta-hydroxymethylsimvastatin, 6’beta-carboxysimvastatin, 6’-beta-hydroxysimvastatin, 6’-exomethylenesimvastatin, simvastatin acid (tenivastatin), simvastatin acid glucuronide and 3’hydroxysimvastatin,
or a salt thereof, to said subject by intravenous administration, not more than 60 minutes after the onset of ischemia, and wherein the ischemia damage is due to an ischemia caused by atherosclerosis, thrombosis, bypass surgery, organ transplantation, ST-elevated myocardial infarction, non-ST-elevated myocardial infarction, or a combination of two or more of these.
22. The state of the art regarding ischemic damage is that it occurs when blood flow is disrupted, leading to oxygen deprivation and cell death, and can manifest in different forms depending on location, including myocardial ischemia (heart), cerebral ischemia (brain, i.e., stroke/TIA), mesenteric ischemia (intestines), and limb/peripheral Ischemia (arms/legs). Ischemic-related damage is categorized by location and severity (e.g., focal vs. global, acute vs. chronic). Damage ranges from temporary dysfunction (relative ischemia) to irreversible tissue death (infarction), due to blockage (thrombosis or embolism). (See webpage printout of https://my.clevelandclinic.org/health/diseases/ischemia, reviewed February 2024). Thus, ischemia and resulting ischemic damage embrace a broad spectrum of morbidity and mortality.
23. The state of the art regarding statins is that they are a class of medications used to lower total cholesterol, low-density lipoprotein (LDL), and triglyceride concentrations while increasing high-density lipoprotein (HDL) concentrations, indicated for the management of hypocholesteremia, hyperlipoproteinemia, and hypertriglyceridemia. Off label uses include nonalcoholic fatty liver disease, cardiac allograft vasculopathy progression, and prevention of contrast-induced acute kidney injury. The FDA-Approved statin medications are available in oral formulations and include FDA-approved statins include atorvastatin, rosuvastatin, simvastatin, pravastatin, fluvastatin, lovastatin, and pitavastatin (Sizar et al., webpage printout of Statin Medications, NCBI Bookshelf 2005).
24. However, O’Neil teaches that statin administration can induce adverse events including hepatic dysfunction, myopathy, myositis, lupus, and interstitial lung disease (see Page 1 under “Introduction”). O’Neil goes on to teach that both simvastatin and atorvastatin cause vasculitis (inflammation of blood vessels) resulting in mesenteric ischemia and intestinal infarction (Page 1 under “Discussion”).
25. As such, one of skill in the art would be unable to fully predict the therapeutic effects of administering atorvastatin or any of its recited derivatives thereof, or simvastatin or any of its recited derivative thereof, for the prevention/ treatment of ischemic damage, let alone the multitude of types of ischemic damage taught by ClevelandClinic.org, as a result of an ischemia caused by atherosclerosis, thrombosis, bypass surgery, organ transplantation, ST-elevated myocardial infarction, non-ST-elevated myocardial infarction, or combinations thereof, as embraced by the instant claims.
26. The level of skill in the art of one tasked with treating or preventing any type of ischemic damage in a subject, i.e., physicians represent one of ordinary skill in the art.
27. The Level of Predictability in the Art: Applicant provides working examples demonstrating the effect of atorvastatin on cardiac ischemia-related damage as a result of an ischemia caused by myocardial infarction in a pig model (Examples 1-3 and 5-10); the effect of atorvastatin or simvastatin on cardiac ischemic damage as a result of an ischemia caused by myocardial infarction in a mouse model (Examples 4 and 7); the effect of atorvastatin on cardiac ischemic damage (myocardial scar formation) as a result of an ischemia caused by myocardial infarction in a rat model (Example 11); and the effect of atorvastatin on cardiac ischemic damage as a result of an ischemia caused by myocardial infarction in pigs with comorbidities (Examples 12-14). As such, the Specification does not support the broad claim to prevention/ treatment of a multitude of types of ischemic damage in various tissues/ organs or combinations thereof, as a result of ischemia caused by different events/pathologies.
38. Hence, in the absence of a showing of correlation between all types and kinds of ischemic damage produced in any/ all of the tissues and/or organs embraced by the language of claim 1, as capable of being treated by any of the statins recited in the table of claim 1, one of skill in the art is unable to fully predict possible results from the administration of the compound(s) of the instant claims for treating the scope of ischemic-related damage resulting from the pathologies encompassed by claim 1.
29. This unpredictability is certainly true in the case of treating or preventing ischemic-related damage in the heart, kidney, intestine, pancreas, liver, lung, skeletal muscle, and/or combinations thereof, which, as disclosed by ClevelandClinic.org above, are complex and varied in etiology as well as severity of pathology:
“Ischemic-related damage is categorized by location and severity (e.g., focal vs. global, acute vs. chronic). Damage ranges from temporary dysfunction (relative ischemia) to irreversible tissue death (infarction), due to blockage (thrombosis or embolism).” (Page 1 of ClevelandClinic.org).
30. There is no question Applicant’s instant statins may play a role in future methods of treating certain of the aforementioned types of ischemic damage. What is disputed is the claim that the recited method could be employed by one skilled in the art at the effective filing date of the claimed invention and used as prevention/treatment for any/ all types and kinds of ischemic damage resulting from any of the types of ischemia embraced by the claims, without undue experimentation. There is simply no evidence to be found in the literature suggesting that Applicant’s compounds are capable of being used in the manner recited. In essence, there is no absolute predictability in pharmacology, even with compounds whose properties have been determined, despite the extraordinarily high skill possessed by the ordinary artisan.
31. The Amount of Direction Provided by the Inventor / Existence of Working Examples: The amount of direction provided by the Applicant is considered to be determined by the Specification and the working examples. In the instant case, the Specification provides fourteen working examples that demonstrate: the effect of atorvastatin on cardiac ischemia-related damage as a result of an ischemia caused by myocardial infarction in a pig model (Examples 1-3 and 5-10); the effect of atorvastatin or simvastatin on cardiac ischemic damage as a result of an ischemia caused by myocardial infarction in a mouse model (Examples 4 and 7); the effect of atorvastatin on cardiac ischemic damage (myocardial scar formation) as a result of an ischemia caused by myocardial infarction in a rat model (Example 11); and the effect of atorvastatin on cardiac ischemic damage as a result of an ischemia caused by myocardial infarction in pigs with comorbidities (Examples 12-14). As such, all of the working examples are limited to the treatment of ischemia-related cardiac damage in a subject comprising administering either atorvastatin or simvastatin, wherein the ischemia is due to a myocardial infarction.
32. Scope or Breadth of the Claims: As stated in MPEP 2164.01©, “[w]hen a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation.” Thus, as stated in MPEP 2164.08, “[t]he focus of the examination inquiry is whether everything within the scope of the claim is enabled” (emphasis added). The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright, 999 F.2d 1557 (Fed. Cir. 1993) (emphasis added).
33. At the same time, however, it is also recognized that not everything necessary to practice the invention need be disclosed. Nor is it necessary that an Applicant test all the embodiments of his invention. In re Angstadt, 537 F.2d 498 (CCPA 1976) (emphasis added). In fact, as stated by the court in In re Buchner, 929 F.2d 660 (Fed. Cir. 1991), a patent need not teach, and preferably omits, what is well known in the art.
34. Accordingly, for purposes of enablement, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate in scope with the protection sought by the claims. Thus, while “a patent application is entitled to claim his invention generically” it is necessary that “he provide a disclosure sufficient to enable one skilled in the art to carry out the invention commensurate with the scope of his claims.” Amgen, Inc, v. Chugai Pharmaceutical Co., Ltd. (Fed. Cir. 1991). As noted by the court in In re Fisher, 427 F.2d 833 (CCPA 1970), the scope of enablement must bear a “reasonable correlation” to the scope of the claims. As stated in MPEP 2164.08, resolution of this concern requires two stages of inquiry: “[t]he first is to determine how broad the claim is with respect to the disclosure. The entire claim must be considered. The second inquiry is to determine if one skilled in the art is enabled to make and use the entire scope of the claim without undue experimentation”.
35. As to the first inquiry, as discussed above, the claims are drawn to a method of preventing and/or reducing ischemia damage in a subject, comprising administering a compound or salt thereof to said subject by intravenous administration, not more than 60 minutes after the onset of ischemia, wherein the compound is:
atorvastatin, or a recited derivative thereof, or simvastatin, or a recited derivative thereof, or a salt thereof, and wherein the ischemia damage is due to an ischemia caused by: atherosclerosis, thrombosis, bypass surgery, organ transplantation, ST-elevated myocardial infarction, non-ST-elevated myocardial infarction, or a combination of two or more of these.
36. Thus, considering that the recited ischemia-related damage embraces damage that occurs in any tissue or organ selected from the heart, kidney, intestine, pancreas, liver, lung, skeletal muscle, and combinations thereof, wherein the ischemia damage is due to an ischemia caused by: atherosclerosis, thrombosis, bypass surgery, organ transplantation, ST-elevated myocardial infarction, non-ST-elevated myocardial infarction, or a combination of two or more of these, wherein treatment or prevention comprises administering a compound that is:
atorvastatin, beta-oxidized atorvastatin, unsaturated beta-oxidized atorvastatin, beta-oxidized hydroxy atorvastatin, 4-hydroxy atorvastatin, para-hydroxy atorvastatin acid, atorvastatin lactone, atorvastatin acyl glucuronide, 2-hydroxy atorvastatin, ortho-hydroxy atorvastatin acid, 4-hydroxy atorvastatin acyl glucuronide, 4-hydroxy atorvastatin lactone, and 2-hydroxy atorvastatin lactone, or
simvastatin, 3’,5’-dihydrodiolsimvastatin, 6’beta-hydroxymethylsimvastatin, 6’beta-carboxysimvastatin, 6’-beta-hydroxysimvastatin, 6’-exomethylenesimvastatin, simvastatin acid (tenivastatin), simvastatin acid glucuronide and 3’hydroxysimvastatin,
or a salt thereof, it is evident that the claims are broad. Yet, as discussed above, the instant Specification discloses only fourteen working examples of treating ischemia-related damage in the heart as a result of ischemia caused by a myocardial infarction, comprising administering atorvastatin or simvastatin. As such, the claim is extremely broad with respect to the disclosure. The second inquiry is discussed in detail below.
37. Amount of Experimentation Necessary: In view of all of the foregoing, at the time the invention was made, it would have required undue experimentation to practice the entire scope of the invention as claimed. As discussed above, the claims are drawn to a method of preventing and/or reducing ischemia-related damage in a subject, comprising administering a compound or salt thereof to said subject by intravenous administration, not more than 60 minutes after the onset of ischemia, wherein the compound is atorvastatin, or a recited derivative thereof, or simvastatin, or a recited derivative thereof, or a salt thereof, and wherein the ischemia damage is due to an ischemia caused by: atherosclerosis, thrombosis, bypass surgery, organ transplantation, ST-elevated myocardial infarction, non-ST-elevated myocardial infarction, or a combination of two or more of these. Since identifying any ischemia-related damage in any of the recited tissues or organs that is capable of being treated, let alone prevented, by administering any of the recited statins is extremely complex, the nature of the instant invention considered to be one of extreme complexity. In the instant case, this complexity is exacerbated by the challenges of treating/preventing any/ all types of ischemic damage in a tissue and/or organ selected from heart, kidney, intestine, pancreas, liver, lung, skeletal muscle, and combinations thereof (see above paragraphs 22-25) as well as the breath of the claims. Although the relative skill of those in the art to which the invention pertains is high, the state of the art and unpredictability within the art is such that even the most talented artisan could not reasonably predict what ischemia-related damage in which tissue/organ encompassed by the claims would be treatable based on the limited disclosure of fourteen working examples, all directed to the treatment of ischemia-related damage in the heart due to ischemia caused by a myocardial infarction, comprising administering either atorvastatin or simvastatin. That is, the only way one skilled in the art is enabled to use the entire scope of the claim based on the instant disclosure entails undue experimentation.
38. To overcome this rejection, Applicant should narrow the scope of the claims such that they bear a reasonable correlation with the disclosure.
Previous Claim Rejections - 35 USC § 103
39. Claims 1-8, 10-14, 21, 22, and 25-33 were previously rejected under 35 U.S.C. 103 as being unpatentable over Sironi et al., Arterioscler Thromb Vasc Biol. (2003), in view of Vilahur et al., WO 2015181216 A1, as evidenced by Zhang et al., JCBFM (1997).
40. In view of Applicant’s amendment to claim 1 to limit the ischemia to a tissue or organ selected from the group consisting of heart, kidney, intestine, pancreas, liver, lung, skeletal muscle and combinations thereof, (i.e., excluding brain ischemia) the previous obviousness rejection is withdrawn.
41. Claim 15 was previously rejected under 35 U.S.C. 103 as being unpatentable over Sironi et al., (Arterioscler Thromb Vasc Biol. 2003), in view of Vilahur et al., (WO 2015181216 A1), as evidenced by Zhang et al., (JCBFM 1997), as applied to claims 1-8, 10-14, 21, 22 and 25, as evidenced by MerckManuals.com, (webpage printout 2021).
42. In view of Applicant’s amendment to claim 1 to limit the ischemia to a tissue or organ selected from the group consisting of heart, kidney, intestine, pancreas, liver, lung, skeletal muscle and combinations thereof, (i.e., excluding brain ischemia) the previous obviousness rejection of claim 15 is withdrawn.
Claim Objections
43. Claim 4 was previously objected to under 37 CFR 1.75 as being a substantial duplicate of claim 1 and not being further limiting. In view of the cancellation of claim 4, the previous objection is withdrawn.
Conclusion
44. In conclusion, claims 1-3, 5-7, 10-15, 21, 22, and 25-33 are pending in the application, and all claims are currently rejected. No claim is presently allowed.
45. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached on Monday-Friday 8:30AM-5PM EST.
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/JANET L COPPINS/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628