DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/06/2025 has been entered.
Claims 22 and 27 have been amended. Claims 23-24 have been newly canceled and no claims have been newly added.
Claims 22 and 25-27 are currently pending and have been examined on their merits.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 61/449448, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Provisional Application 61/449448 fails to provide support for a dosage of 0.2 mg/kg to about 12 mg/kg (or the previously claimed dosage of 0.01 ml/kg to 1 ml/kg) or wherein the infarct volume is reduced by about 70% to about 90%.
Since there appears to be support for the claims in PCT/US12/27307, the claims have been examined with the filing date of March 1, 2012.
Claim Interpretation
Regarding amended claim 22, the new dosage limitations have been arrived at by taking the disclosure at paragraph 78 of the published specification which states “0.1 to about 0.6 cc per kg body weight with 2% w/vol DDFPe’” and converting the units with the following calculations: 0.01 mL/kg x 2g/100mL= 0.2 mg/kg and 0.6mL/kg x 2g/100mL= 12 mg/kg (see Applicants response bottom of page 5).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 22 and 25-27 are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over Keipert et al (US 2005/0049359) in view of Unger et al (US 6,443,898) and Johnson et al (Artificial Cells, Blood Substitutes, and Biotechnology, 2009).
Regarding claim 22, Keipert discloses a method for improving tissue oxygenation in a subject at risk for ischemic tissue damage and reducing the infarct volume in a tissue of a mammalian subject undergoing ischemia resulting from an ischemic event (page 2 para 11, page 3 para 29). The method comprises administering an effective amount of a composition comprising a perfluorocarbon emulsion to a subject (page 2 para 11) prior to a medical procedure that results in the subject being at high risk of ischemic tissue damage (page 2 para 19). The perfluorocarbon has a boiling point below about 100 °C as compounds having the general formula CnF2n+1 -Cn’F2n’+1 where n and n’ are the same or different and are from about 1-10 and so long as the compound or mixture containing the compound is a liquid at room temperature (page 5 para 44) (CSF 12 also known as dodecafluoropentane or perfluoropentane has a boiling point below 100 °C and is liquid at room temperature).
Keipert discloses that the composition comprising the perfluorocarbon emulsion is administered in a time ranging from immediately after the start of the ischemic event (as soon as detected or suspected-including after onset of symptoms) to about 24 hours after the onset of symptoms (pages 7-8, para 67-68). Keipert also discloses that the composition is administered at more than one time point (page 2 para 20). Keipert discloses that preferably about 0.50 to 1 ml/kg of a perfluorocarbon emulsion is administered by injection or infusion during the first hour of therapy and then during the next day (24 hours) to 7 days, additional volumes (e.g. about 2 ml/kg to about 10 ml/kg) of a perfluorocarbon emulsion can be administered depending on the additional surgical or nonsurgical treatment given, as determined by the treating physician (page 8 para 68). That is as long as the physician determines or suspects that hypoxia or ischemia is resulting from a solid occlusion of a blood vessel, administration of the synthetic oxygen carrier is continued until the physician has determined that the vessel is no longer occluded (page 8 para 68). The fluorocarbons may be present in the emulsion in any useful concentration and those as low as 5% w/v are contemplated (interpreted as about 5% w/v) (page 5 para 40-41). Administration over a sustained period of time is also contemplated (page 4 para 32).
Keipert disclose that when used intravenously, the volume of administered emulsion may vary based on clinical parameters. Acute treatment involves intravenous administration during the first 5 minutes to hour of therapy and may continue for about 24 hours (page 7 para 68). Keipert also disclose wherein the composition is administered as a bolus (page 7 para 65).
Keipert teaches that the perfluorocarbon is preferred (page 4 para 40) and that other fluorocarbons not listed but having properties described that would lend themselves to use in vivo in accordance with the reference invention are further contemplated (page 5 para 44).
Keipert discloses wherein the medical procedure is selected from a group consisting of vascular surgery, neural surgery, cardiac surgery (page 2 para 19, page 4 para 32), catherization or angioplasty (page 9 para 76).
Keipert discloses wherein the ischemic event is further resolved after administration of the compound by administering other therapeutic agents, including tPA (thrombolytic agent)(page 8 para 71).
Keipert et al does not specifically include using DDFPe as the type of perfluorocarbon to be used.
Unger et al teach therapeutic delivery systems comprising a gaseous precursor- filled microspheres comprising a therapeutic (abstract). The microspheres may be used for targeted therapeutic delivery in vivo (column 7 lines 35-36). Perfluoropentane (also known as DDFPe or dodecafluoropentane and which has a boiling point of less than 37°C) is suggested as a liquid perfluorocarbon precursor to be used wherein upon rewarming (e.g. injection in vivo) becomes a gas (column 9 lines 42-67 and column 8 lines 4-20). A microcellular formulation is suggested and includes a microfluidized process nanoparticles or microparticles of the emulsion wherein each particle entraps the perfluoropentane (column 10 lines 28-37). Emulsions of perfluoropentane can be used to deliver drugs and vasoactive compounds to ischemic regions (column 23 lines 28-55). The gaseous precursors undergo phase transition at close to body temperature and tend to accumulate in ischemic tissue (column 33 lines 9-35).
Johnson teach the use of an agent to extend the window of time for tissue viability so either thrombus dissolving or recanalization life-saving treatments, such as tPA, can be used beyond the 3 hour limit (page 156, Introduction). Johnson teach that a 2% w/v sub-microemulsion of dodecafluoropentane (DDFP) (also known as perfluoropentane) was developed for the treatment of stroke and has been shown to be safe in humans (page 156, column 2). Johnson explicitly teach that 2% w/v DDFP offers a strong advantage over PFD and PFOB in that a much smaller dose can be administered to achieve the desired result (page 160 Conclusion to page 161).
Therefore, one of ordinary skill in the art would have been motivated to use DDFPe in the method of Keipert et al as the perfluorocarbon used to treat an ischemic event and/or prior to a medical procedure that increases the risk of an ischemic event, because both Unger and Johnson teach that DDFPe is a suitable perfluorocarbon for delivery to ischemic tissue. Administration of DDFPe at about 2% w/v at a dose of about 0.5 ml/kg (concentration disclosed by Johnson and dosage disclosed by Keipert) would have inherently provided a reduced infarct volume of about 70% to 90% as disclosed by the claimed invention (using the same conversion equation as Applicant 0.5 mL/kg x 2g/100mL= 10 mg/kg and which falls in Applicant’s claimed dosage range). One of ordinary skill in the art would have had a reasonable expectation of success because DDFPe is liquid at room temperature which Keipert indicates is required for perfluorocarbons in their method and Johnson teach that DDFP has been shown to be safe in humans.
With regard to the concentrations of perfluorocarbon in the emulsion composition, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05).
The selection of specific concentrations clearly would have been a routine matter of optimization and experimentation on the part of the artisan of ordinary skill, said artisan recognizing that the effectiveness of the therapeutic treatment would have been affected by these concentrations.
Regarding claim 25, Keipert disclose that an infarct size is taught to be reduced (page 3 para 29) without resolving the ischemic event (page 3 para 28). One of ordinary skill in the art would have been motivated to reduce the infarct volume as much as possible without increasing the incidence of brain hemorrhage as the goal of the method is to protect living tissue (page 1 para 2) and because Johnson also suggest the need to avoid brain hemorrhage (page 156 column 2). One of ordinary skill in the art would have had a reasonable expectation of success because Keipert teach that perfluorocarbon emulsions have been used to enhance the recovery brain stem functions following reperfusion (page 1 para 9) and because Johnson teach that a 2% w/v sub-microemulsion of DDFP was proven to carry out respiratory gas transport and maintain tissue viability as well as normal physiological processes in severely anemic rats (page 156, column 2).
Regarding claim 26, Keipert discloses wherein the ischemic event to be treated is stroke (neural ischemic tissue damage) (page 8 para 69-70, page 9 para 76).
Regarding claim 27, Keipert discloses wherein the ischemic event is further resolved after administration of the compound by administering other therapeutic agents, including tPA (thrombolytic agent)(page 8 para 71).
Therefore, the combined teachings of Keipert et al, Unger et al and Johnson et al render obvious Applicant’s invention as claimed.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 22 and 25-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,571,467 in view of Keipert et al (US 2005/0049359).
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the patent are drawn to a method of reducing an infarct volume in a tissue of a subject undergoing ischemia resulting from an ischemic event comprising injecting intravenously into a subject at a time ranging from immediately after the start of the ischemic event to 3 hours after the onset of symptoms, a perfluorocarbon emulsion comprising about 1-5% w/v dodecafluoropentane at a dosage of about 0.2 mg/kg to about 12 mg/kg of the subject, as a bolus, in combination with tPA (thrombolytic agent), wherein the infarct volume is reduced without incidence of brain hemorrhage and wherein the ischemic event is stroke (neural ischemic tissue damage).
The claims of the patent do not include wherein the perfluorocarbon emulsion is administered prior to a medical procedure that results in the subject being at high risk of ischemic tissue damage.
Keipert discloses a method for improving tissue oxygenation in a subject at risk for ischemic tissue damage and reducing the infarct volume in a tissue of a mammalian subject undergoing ischemia resulting from an ischemic event (page 2 para 11, page 3 para 29). The method comprises administering an effective amount of a composition comprising a perfluorocarbon emulsion to a subject (page 2 para 11) prior to a medical procedure that results in the subject being at high risk of ischemic tissue damage (page 2 para 19). The perfluorocarbon has a boiling point below about 100 °C as compounds having the general formula CnF2n+1 -Cn’F2n’+1 where n and n’ are the same or different and are from about 1-10 and so long as the compound or mixture containing the compound is a liquid at room temperature (page 5 para 44) (CSF 12 also known as dodecafluoropentane or perfluoropentane has a boiling point below 100 °C and is liquid at room temperature).
Keipert discloses that the composition comprising the perfluorocarbon emulsion is administered in a time ranging from immediately after the start of the ischemic event (as soon as detected or suspected-including after onset of symptoms) to about 24 hours after the onset of symptoms (pages 7-8, para 67-68). Keipert also discloses that the composition is administered at more than one time point (page 2 para 20). Keipert discloses that preferably about 0.50 to 1 ml/kg of a perfluorocarbon emulsion is administered by injection or infusion during the first hour of therapy and then during the next day (24 hours) to 7 days, additional volumes (e.g. about 2 ml/kg to about 10 ml/kg) of a perfluorocarbon emulsion can be administered depending on the additional surgical or nonsurgical treatment given, as determined by the treating physician (page 8 para 68). That is as long as the physician determines or suspects that hypoxia or ischemia is resulting from a solid occlusion of a blood vessel, administration of the synthetic oxygen carrier is continued until the physician has determined that the vessel is no longer occluded (page 8 para 68). The fluorocarbons may be present in the emulsion in any useful concentration and those as low as 5% w/v are contemplated (interpreted as about 5% w/v) (page 5 para 40-41). Administration over a sustained period of time is also contemplated (page 4 para 32).
Keipert disclose that when used intravenously, the volume of administered emulsion may vary based on clinical parameters. Acute treatment involves intravenous administration during the first 5 minutes to hour of therapy and may continue for about 24 hours (page 7 para 68). Keipert also disclose wherein the composition is administered as a bolus (page 7 para 65).
Keipert teaches that the perfluorocarbon is preferred (page 4 para 40) and that other fluorocarbons not listed but having properties described that would lend themselves to use in vivo in accordance with the reference invention are further contemplated (page 5 para 44).
Keipert discloses wherein the medical procedure is selected from a group consisting of vascular surgery, neural surgery, cardiac surgery (page 2 para 19, page 4 para 32), catherization or angioplasty (page 9 para 76).
One of ordinary skill in the art would have been motivated to administer the perfluorocarbon emulsion of the patent to a subject prior to a medical procedure that places the subject at high risk for an ischemic event because Keipert suggest that perfluorocarbon emulsions are useful both for treating ischemic tissue damage after an ischemic event as well as prior to a medical procedure that increases the risk of an ischemic event. One of ordinary skill in the art would have had a reasonable expectation of success because both the patent and Keipert are drawn to the administration of a perfluorocarbon emulsion with a similar administration time, concentration and dosage for the treatment of ischemic tissue damage.
Therefore, the combined teachings of the claims of the patent and Keipert render obvious Applicant’s invention as claimed.
Response to Arguments
Applicant's arguments filed 08/06/2025 have been fully considered but they are not persuasive.
Applicant argues that Keipert lists an enormous number of oxygen carriers that are allegedly suitable for use for treating tissue damage resulting from hypoxia or ischemia and lists paragraphs 42-44 of Keipert as evidence.
This is not found persuasive. Keipert discloses the properties necessary for the oxygen carrier in their method. Unger and Johnson are relied upon for the specific DDFP oxygen carrier as claimed.
Applicant argues that Keipert does not present any in vivo data.
This is not found persuasive. DDFP and other perfluorocarbons have been used in vivo for many years (as evidenced by Park (US 2010/0055067, page 1, page 3, para 54-56, page 6 para 70-73) and Kiral et al (US 2010/0267842, page 1 para 3, page 2 para 21, page 20, para 338-341)) and as such in vivo data is not necessary for Keipert.
Applicant argues that contrary to the assertion of Keipert that various perfluorocarbons, including Perflubron (PFOB), have been tested and shown to be unsafe and ineffective based on extensive clinical studies. Applicant points to Hill (Exhibit 1) and Keipert 2006 reference (Exhibit 2). Applicant argues that because Keipert et al. only exemplifies one embodiment with the compound PFOB that their disclosure, which is shown to cause adverse effects in patients during clinical trials, all of which were halted due to the severity of these adverse events, is not enabled for any other embodiment or any other alternate compound.
This is not found persuasive. The obviousness rejection includes the teachings of Johnson (see above) which specifically state that a 2% w/v sub- microemulsion of dodecafluoropentane (DDFP) (also known as perfluoropentane) was developed for the treatment of stroke and has been shown to be safe in humans (page 156, column 2). Johnson explicitly teach that 2% w/v DDFP offers a strong advantage over PFD and PFOB in that a much smaller dose can be administered to achieve the desired result (page 160 Conclusion to page 161). Unger et al teach the use of perfluorocarbons, specifically DDFPe which has a low boiling point, that are to be used in vivo for the delivery of therapeutic agents.
The MPEP states that the selection of a known material based on its suitability for its intended use is sufficient support for a prima facie obviousness determination (see MPEP 2144.07 Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)). “Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” 325 U.S. at 335, 65 USPQ at 301.).
Applicant argues that Unger et al does not teach the claimed invention. Applicant specifically points out that Unger et al does not teach or suggest therapeutic use for infarct volume reduction, dosages to deliver according to what time profile in order to achieve a reduction in infarct volume in a tissue of a subject suffering an ischemic event.
This is not found persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Unger et al is cited in the obviousness rejection to demonstrate the use of perfluorocarbons, specifically DDFPe which has a low boiling point (column 9 lines 42- 67 and column 8 lines 4-20), that are to be used in vivo for the delivery of therapeutic agents to ischemic regions in the tissue of a subject (column 23 lines 28-55).
This teaching is deemed sufficient in combination with the teaching of Johnson to motivate the skilled artisan to select DDFPe for the method of Keipert.
Applicant argues that Johnson does not teach or suggest amended claim 22 and is limited to a method for resuscitation of a subject suffering from anemia. Applicant asserts that there is no evidence provided of a direct correlation between resuscitation and reduction of infarct volume and thus Johnson does not provide dosage information relevant to the claimed invention.
This is not found persuasive. Johnson teach the use of an agent to extend the window of time for tissue viability so either thrombus dissolving or recanalization life- saving treatments, such as tPA, can be used beyond the 3 hour limit (page 156, Introduction). Johnson teach that a 2% w/v sub-microemulsion of dodecafluoropentane (DDFP) (also known as perfluoropentane) was developed for the treatment of stroke (ischemic strokes are known to cause infarct tissue) and has been shown to be safe in humans (page 156, column 2). Johnson explicitly teach that 2% w/v DDFP offers a strong advantage over PFD and PFOB in that a much smaller dose can be administered to achieve the desired result (page 160 Conclusion to page 161).
Applicant argues that the studies disclosed in Johnson are all in vitro studies and that Johnson recognizes the limitations due to the in vitro nature of the data and placed conspicuous cautions not to over interpret the same.
This is not found persuasive. Johnson teach that a 2% w/v sub-microemulsion of dodecafluoropentane (DDFP) (also known as perfluoropentane) was developed for the treatment of stroke (ischemic strokes are known to cause infarct tissue) and has been shown to be safe in humans (page 156, column 2).
Applicant asserts that a person of ordinary skill in the art based on the teachings of Keipert, Unger and Johnson would not be able to arrive at the claimed invention. Applicant asserts that Keipert has no enabling teachings and the exemplified compound would have led to the use of unsafe agents and that Unger has dramatically different objectives and underlining principles and that Johnson discloses nothing in regard to the actual doses of DDFP that would be suitable for use in achieving reduction of infarct volume for human stroke patients.
This is not found persuasive. The Office is not the FDA. As far as patentability is concerned the prior art has suggested both the claimed concentration and the claimed dosage as suitable for use in the method of Keipert which combined with the teachings of Unger and Johnson renders obvious the claimed invention as described above.
Applicant argues that the claims of the ‘467 Patent in view of Keipert do not teach or suggest the amended claims. Applicant argues that the disclosure of the patent may not be used as prior art. Applicant argues that there is no issue of unjust extension of patent term in the instant context because the present application is a continuation of the reference patent and both are subject to the same priority filing date and thus the policy considerations underlying the double patenting doctrine do not apply in the instant context.
This is not found persuasive. First, the patent in view of Keipert do in fact teach and suggest the amended claims as described above. Second, the specification of the patent is not relied upon in the double patenting rejection. Third, the policy considerations of double patenting do apply even when the reference patent and the pending claims are related by continuation status.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Quinlan et al., “Perfluorocarbon Liquids in Vitreoretinal Surgery”, Retinal Physician, 2006, https://retinalphysician.com/issues/2006/novdec/perfluorocarbon-liquids-in-vitreoretinal-surgery/ , pp.1-8.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/ Primary Examiner, Art Unit 1631