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 .
This Office action is responsive to Applicant’s amendment and remarks, filed 11 Sep 2025, in which claim 6 is amended to correct informalities, claim 44 is canceled, and new claims 47-49 are added.
This application is a domestic application, filed 24 Jan 2024; claims benefit as a CON of 17/362,254, filed 29 June 2021, issued as PAT 11,911,412; and claims benefit as a CON of 15/752852, which is a 371 of PCT/US2016/046829, filed 12 Aug 2016, issued as PAT 11,077,135; which claims benefit of provisional application 62/205,408, filed 14 Aug 2015.
Claims 1-8, 27-32, 41-43, and 45-49 are pending in the current application and are examined on the merits herein.
Objections Withdrawn
Applicant’s amendment, filed 11 Sep 2025, with respect that claim 6 objected to because of informalities has been fully considered and is persuasive, as amended claim 6 clearly ends in a period.
This objection has been withdrawn.
Rejections Withdrawn
Applicant’s amendment, filed 11 Sep 2025, with respect that claim 44 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite has been fully considered and is persuasive, as claim 44 is canceled.
This rejection has been withdrawn.
The following are modified grounds of rejection necessitated by Applicant’s amendment, filed 11 Sep 2025, in which claim 44 is canceled, and new claims 47-49 are added.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Amended Claims 1-8, 27-32, 41-43, and 47-49 are rejected under 35 U.S.C. 103 as being unpatentable over the '785 application (Baker et al. US 2014/0080785, published 20 Mar 2014, provided by Applicant in IDS filed 29 Jan 2024) in view of the '474 application (Baker et al., US 2010/0056474, published 04 Mar 2010, provided by Applicant in IDS filed 29 Jan 2024).
The '785 application teaches methods of treating a subject that has been or will be exposed to radiation, trauma or shock with a compound of formula (I) that treats, reduces the severity or delays the onset of sepsis or reduces the likelihood of mortality (abstract; page 1, paragraph 0005), wherein the formula (I) is characterized by the same structure as recited in claim 1. The '785 application teaches shock is a failure of the circulatory system to supply sufficient blood to peripheral tissues to meet basic needs including metabolic requirements for oxygen and nutrients and incomplete removal of metabolic wastes from the affected tissues. Shock is usually caused by hemorrhage or overwhelming infection. Shock may result from a variety of physiological mechanisms, including sudden reductions in the total blood volume such as severe hemorrhage; sudden reductions in cardiac output, as in myocardial infarction (heart attack); and widespread dilation of the blood vessels, as in some forms of infection (page 12, paragraph 225), suggesting the treatment of a disorder of the vascular system such as ischemia or hemorrhagic shock. The '785 application teaches methods of treating a subject who has sepsis and treating phenotypes of associated with septicemia and septic shock. (page 13, paragraph 230). In some embodiments the subject has suffered reperfusion injury, e.g., treated to restore blood circulation (page 2, paragraph 19), addressing claim 2. In some embodiments the method reduces local or system inflammation, (page 2, paragraph 27) addressing claim 3. In some embodiments the polyglucosamine is a chitosan soluble at physiological pH (page 6, paragraph 0125; page 7 paragraph 0127-0133), addressing claim 27. In some embodiments the functionalized polyglucosamine is soluble in aqueous solution between pH 6.8 and pH 7.4 (page 9, paragraph 0153). In some embodiments the molecular weight of the derivatized chitosan is from 50 to 150 kDa (page 2, paragraph 0035; page 9, paragraph 0152), addressing claim 28. In some embodiments the derivatized chitosan is functionalized at between 18% and 30% (page 2, paragraph 0034) or between 15% and 35% (page 9, paragraph 0157), addressing claims 29. The '785 application teaches exemplary a charged polyglucosamine, e.g., poly (acetyl, arginyl) glucosamine (page 6, paragraph 125), addressing claims 31-21. In another embodiment the effective amount is 5 to 500 mg/kg or 1 to 50 mg/kg. (paragraph 0167 spanning pages 9-10). The compounds described can be formulated in a variety of manners for different routes of delivery (page 18, paragraph 0274). The '785 application teaches in some embodiments, the subject is treated within 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours, 24 hours, 2 days, 3 days, 4 days, 5 days, 6 days, 1 week, or 2 weeks after exposure to the cause of injury (page 19, paragraph 287), addressing claims 47-49.
The '785 application does not specifically disclose the method comprising intravenously administering said compound of formula (I) (instant claim 1).
The '474 application teaches treatment and prevention of nosocomial infections or MRSA infections utilizing soluble chitosan or chitosan derivative compounds, e.g. chitosan-arginine. (abstract) The '474 application teaches the chitosan derivative compounds, e.g. chitosan-arginine, having the same chemical structure as recited in claim 1. (page 3, paragraph 55-71). The compounds can be formulated in a variety of manners, including for oral, topical or systemic delivery (e.g., administered orally, parenterally, by inhalation spray (e.g., nasal spray), nebulizer, topically, rectally, nasally, buccally). The compounds (e.g., a soluble chitosan or a derivatized chitosan) can, for example, be administered by injection, intravenously, intraarterially, or orally. Typically, the pharmaceutical compositions of this invention will be administered from about 1 to about 6 times per day. Alternatively, the compounds can be administered as a continuous infusion. (page 26, paragraph 596-597)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the '785 application in view of the '474 application to select the route of administration to be intravenous administration. One of ordinary skill in the art would have been motivated to combine the teachings of the '785 application in view of the '474 application with a reasonable expectation of success because both the '785 application and the '474 application are drawn to therapeutic treatment comprising administering an effective amount of a chitosan-arginine and both encompass treatment of bacterial infection or sepsis caused by thereby, the '785 application teaches the compounds described herein can be formulated in a variety of manners for different routes of delivery, and the '474 application teaches the compounds can be effectively administered by either oral or intravenous injection routes. Further, the '474 application teaches the administration may be administered alternatively as a continuous infusion, implying the other disclosed alternative is a bolus injection. Regarding claim 2, it would have been obvious for one of ordinary skill in the art to reasonably expect the method of treating shock as a disorder of the vascular system taught by the '785 application to result in restoring normal blood transport.
Regarding claims 4-5, 7 and 46, the '785 application in view of the '474 application does not specifically teach the results, functional properties, or mechanism of action of the method of treatment to be to reduce the permeability of the blood brain barrier, enhance the integrity of the blood brain barrier, the method reduces VEGF-mediated deterioration, or the method provides increased stability or structure, promotes endothelial integrity, restoring glycocalyx integrity, or reduces abnormal fluid transport across the glycocalyx. Regarding claim 6 and 45, the specification as filed states that the glycocalyx is involved in endothelial damage, e.g., caused by sepsis, localized or systemic inflammation. MPEP 2112.01 especially at I. citing In re Best, 562 F.2d 1252, 195 USPQ 430 (C.C.P.A. 1977) and In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly recited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to show the products of the applicant and the prior art are not the same or that the prior art products do not necessarily possess the characteristics of the claimed product. See also MPEP 2112.02 at II. citing In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966) providing '"While the references do not show a specific recognition of that result, its discovery by appellants is tantamount only to finding a property in the old composition." 363 F.2d at 934, 150 USPQ at 628 (emphasis in original)).' In this case both the '785 application and the '474 application teach the therapeutic treatment comprising administering an effective amount of a chitosan-arginine as claimed and the '785 application teaches administration of the same amount to treat the same conditions, therefore there is reason to believe the prior art inherently includes functions, results, or mechanisms of action that are newly recited.
Regarding claims 4 and 5, the evidence of record provided in the parent application 15/752852 has been considered despite being directed to the system described in the application and not to the individual claims of this application, and is not found to be persuasive or commensurate with the scope of claims 4-5 herein. For example, claims 4 and 5 encompass the recited functions, results, or mechanisms of action in the context of treatment of sepsis that is unrelated to the brain or the blood brain barrier. See MPEP 716.01(b) providing "To be given substantial weight in the determination of obviousness or nonobviousness, evidence of secondary considerations must be relevant to the subject matter as claimed, and therefore the examiner must determine whether there is a nexus between the merits of the claimed invention and the evidence of secondary considerations. Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 305 n.42, 227 USPQ 657, 673-674 n. 42 (Fed. Cir. 1985), cert. denied, 475 U.S. 1017 (1986). In this case the evidence of record provided in the parent application 15/752852 is not persuasive in view of the relied upon teachings of the '785 application in view of the '474 application for treatment of disorders which are not related to the brain or the blood brain barrier, where the '474 application provides guidance and a reasonable expectation of success for administration by the intravenous route, for example to treat a bacterial infection. For similar reasons, the evidence of record provided in the parent application 15/752852 is not persuasive or commensurate with the scope of claim 8 because claim 8 encompasses disorders other than brain injury, traumatic brain injury, and brain damage, and it has not been established if the evidence is commensurate with treatment of ischemia, sepsis, or septic shock.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 11 Sep 2025, have been fully considered and not found to be persuasive.
Applicant notes that the '474 application is drawn to treatment and prevention of nosocomial infections or MRSA infections utilizing soluble chitosan or chitosan derivative compounds, e.g. chitosan-arginine and remarks that this different from the specific conditions treated in the '785 application, and that there would have been no motivation to modify the teachings of the '785 application with the teachings of the '474 application. However, as detailed n the rejection of record, both the '785 application and the '474 application are drawn to therapeutic treatment comprising administering an effective amount of a chitosan-arginine and both encompass treatment of bacterial infection or sepsis caused by thereby, the '785 application teaches the compounds described herein can be formulated in a variety of manners for different routes of delivery, and the '474 application teaches the compounds can be effectively administered by either oral or intravenous injection routes. One of ordinary skill in the art would have understood that sepsis or septic shock is caused by the immune response to an infection, such as a bacterial infection, therefore it is reasonable that one of ordinary skill in the art starting from the '785 application which encompasses different routes of delivery would have looked to the teachings of the '474 application to select the route of delivery to be intravenous.
Applicant remarks that the claimed invention provided unexpected results regarding glycocalyx shedding, inflammation of the brain, and blood brain barrier permeability. These results are not commensurate in scope with the claimed invention because the scope of the claims encompass treatment of ischemia, sepsis, or septic shock. As detailed in the rejection of record, it is unclear that how this evidence of unexpected results would affect or improve treatment of ischemia, sepsis, or septic shock which is not related to the brain or the blood brain barrier.
Claims 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over the '785 application (Baker et al. US 2014/0080785, published 20 Mar 2014, provided by Applicant in IDS filed 29 Jan 2024) in view of the '474 application (Baker et al., US 2010/0056474, published 04 Mar 2010, provided by Applicant in IDS filed 29 Jan 2024) as applied to claims 1-8, 27-32, 41-43, and 47-49 above, and further in view of Mulivor et al. (Am. J. Physiol. Heart Circ. Physiol., 2004, 2, pages H1672-H1680, of record) and Burke-Gaffney et al. (Critical Care, 2012, 16, article 121, 2 pages, of record).
The '785 application in view of the '474 application teaches as above.
The '785 application in view of the '474 application does not specifically teach the method of treating a disorder in a subject in need thereof, wherein the disorder is dysfunction of the glycocalyx or loss of structural integrity of the glycocalyx. (claim 45)
Mulivor et al. teaches investigation into alterations in the composition of the glycocalyx of venular endothelium in models of inflammation and ischemia-reperfusion injury (abstract, page H1672). It is well recognized that the glycocalyx of the endothelial cell (EC) serves as a barrier to transvascular exchange of macromolecules and blood cell adhesion to the endothelium and may affect the resistance to blood flow within the microcirculation proper (page H1672, left column, paragraph 1). There is sufficient in vitro evidence to suggest that components of the glycocalyx are shed in response to signal transduction events common to inflammation and ischemia-reperfusion (page H1672, right column, paragraph 4).
Burke-Gaffney et al. teaches disruption and dysfunction of the microvascular endothelium leading directly or indirectly to multiple organ failure are now recognized to underpin the pathophysiology of sepsis (page 1, abstract). The endothelial glycocalyx is fundamental in regulating vascular integrity and functions central to the pathophysiology of sepsis (page 2, left column, paragraph 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the '785 application in view of the '474 application further in view of Mulivor et al. and Burke-Gaffney et al. to select the treatment of ischemia or sepsis as a dysfunction of the glycocalyx or a loss of structural integrity of the glycocalyx. One of ordinary skill in the art would have been motivated to combine the '785 application in view of the '474 application further in view of Mulivor et al. and Burke-Gaffney et al. with a reasonable expectation of success because the '785 application in view of the '474 application teach a method for treatment of ischemia or sepsis, Mulivor et al. teaches ischemia is a disorder that causes loss of structural integrity of the glycocalyx, and Burke-Gaffney et al. teaches disruption and dysfunction of the endothelial glycocalyx is central to the pathophysiology of sepsis, suggesting it would have been obvious that the patient for treatment of ischemia or sepsis is also in need of treatment for dysfunction of the glycocalyx, and that the method would be effective to restore blood circulation.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 11 Sep 2025, have been fully considered and not found to be persuasive.
Applicant’s remarks that the applicant provides evidence that the claimed invention provides an unexpected result in the aspect of the glycocalyx shedding or thickness. However, this result in Example 5 of the application is drawn to the treatment of hemorrhagic shock, and is not commensurate in scope with the claim. It is not clear from this one example that this same result is predicted for treatment of other conditions or whether this result is specific to the treatment of hemorrhagic shock, since Mulivor et al. and Burke-Gaffney et al. suggest role of the endothelial glycocalyx in ischemia or sepsis. See also MPEP 716.02(b), especially at II., providing that applicants have the burden of explaining the data they proffer as evidence of non-obviousness. In this case an explanation has not been provided that unexpected result in the aspect of the glycocalyx in Example 5 would have been reasonably predicted for treatment of other conditions commensurate in scope with the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2, 4-8, 27-32, and 45-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,077,135 (reference patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims 1-12 of the reference patent are drawn to a method of treating a disorder of the vascular system, the method comprising intravenously administering a polymer to a subject in need thereof, thereby treating the disorder, wherein the disorder is traumatic brain injury; and wherein the polymer is a compound of the structure recited in claims 1 and 45. The disorder treated of traumatic brain injury is recited in claim 8 and is encompassed within the scope of brain injury or brain damage recited in claim 8. Reference Claims 2-10 of the reference patent correspond to claims 2, 4, 5, 6, 7, 27, 28, 29, and 30, respectively.
Regarding claims 45-46, Reference claims 1 and 5 indicate the disorder of traumatic brain injury is a result of dysfunction of the glycocalyx or loss of structural integrity of the glycocalyx, and Reference claims 3-4 recite the method reduces the permeability or enhances the integrity of the blood brain barrier, implying the method restores glycocalyx structure or integrity.
Amended Claims 3, 41-43, and 47-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,077,135 (reference patent) in view of '785 application (Baker et al. US 2014/0080785, published 20 Mar 2014, cited in PTO-892) and '474 application (Baker et al., US 2010/0056474, published 04 Mar 2010, cited in PTO-892).
Reference Claims 1-12 of the reference patent recite as above.
Reference Claims 1-12 do not specifically recite the disorder is inflammation, swelling and secondary damage of the vascular and lymphatic system. (claim 3) Reference Claims 1-12 do not specifically recite the intravenous administration is by bolus administration, continuous infusion, or intraarterial. (claims 41-43) Reference Claims 1-12 do not specifically recite the time frame after the injury the administration is made. (claims 47-49)
The '785 application teaches as above, particularly with regard to the time frame after the injury the administration is made. The '785 application also teaches in some embodiments the method reduces local or system inflammation.
The '474 application teaches as above, particularly with regard to the types of intravenous administration.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-12 in view of the '785 application and the '474 application in order to select from within the scope of the reference claims the types of intravenous administration, the time frame after the injury the administration is made, or for the method to treat inflammation. One of ordinary skill in the art would have been motivated to combine Reference claims 1-12 in view of the '785 application and the '474 application with a reasonable expectation of success because all of the references are drawn to therapeutic treatment comprising administering the same chitosan-arginine structure, both Reference claims 1-12 of the reference patent and the '785 application encompass treatment of brain injury comprising administering the same compound and the '785 application provides guidance that one of ordinary skill in the art would select the time frame after the injury the administration is made, and both Reference claims 1-12 and the '474 application encompass intravenous administration of the same compound and the '474 application provides guidance that one of ordinary skill in the art would select the types of intravenous administration.
Claims 1-8, 27-32, 41-43, and 45-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,911,412 (reference patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims 1-16 of the reference patent are drawn to a method of treating hemorrhagic shock, the method comprising intravenously administering a polymer to a subject in need thereof, thereby treating the disorder; and wherein the polymer is a compound of the structure recited in claims 1 and 45. The disorder of hemorrhagic shock is a disorder of the vascular system addressing limitations of claims 1 and 8. Reference Claims 2-10 correspond to limitations of claims 2, 4, 5, 6, 7, 27, 28, 29, and 30, respectively. Reference claims 11-15 correspond to limitations of claims 31, 32, 41, 42, and 43, respectively. Regarding claims 45-46, reference claim 5 recites the hemorrhagic shock is a result of dysfunction of the glycocalyx or loss of structural integrity of the glycocalyx, and reference claims 3-4 recite the method reduces the permeability or enhances the integrity of the blood brain barrier, implying the method restores glycocalyx structure or integrity.
Amended Claim 3 and 47-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,911,412 (reference patent) in view of '785 application (Baker et al. US 2014/0080785, published 20 Mar 2014, cited in PTO-892) and '474 application (Baker et al., US 2010/0056474, published 04 Mar 2010, cited in PTO-892).
Reference Claims 1-16 of the reference patent recite as above.
Reference Claims 1-16 do not specifically recite the disorder is inflammation, swelling and secondary damage of the vascular and lymphatic system. (claim 3) Reference Claims 1-16 do not specifically recite the time frame after the injury the administration is made. (claims 47-49)
The '785 application teaches as above, particularly with regard to the time frame after the injury the administration is made. The '785 application also teaches in some embodiments the method reduces local or system inflammation.
The '474 application teaches as above, particularly with regard to the types of intravenous administration.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-16 in view of the '785 application and the '474 application in order to select from within the scope of the reference claims the types of intravenous administration or the time frame after the injury the administration is made. One of ordinary skill in the art would have been motivated to combine Reference claims 1-16 in view of the '785 application and the '474 application with a reasonable expectation of success because all of the references are drawn to therapeutic treatment comprising administering the same chitosan-arginine structure, both Reference claims 1-16 and the '785 application encompass treatment of hemorrhagic shock comprising administering the same compound and the '785 application provides guidance that one of ordinary skill in the art would select the time frame after the injury the administration is made, and both Reference claims 1-16 and the '474 application encompass intravenous administration of the same compound and the '474 application provides guidance that one of ordinary skill in the art would select the types of intravenous administration.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 11 Sep 2025, have been fully considered and not found to be persuasive.
Regarding each of the nonstatutory double patenting rejections above, no terminal disclaimer is recorded, therefore it is proper to maintain the rejections.
Conclusion
No claim is found to be allowable.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693