DETAILED ACTION
Applicants’ arguments, filed 4 September 2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Interpretation - Adenosine
Claim 1 recites liposomes that encapsulate adenosine. The examiner takes the position that the term “adenosine” is understood to refer to the following compound, which is shown below with stereochemistry.
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The examiner notes that compounds such as adenosine monophosphate, adenosine diphosphate, and adenosine trisphosphate are known in the art. For the purposes of examination under prior art, these are not understood to read on the required adenosine. This is because the adenosine phosphates include the structure of adenosine being covalently bound to a phosphate group, causing it to be a completely different chemical compound and no longer to be adenosine.
As such, the examiner has not rejected the instant claims over prior art drawn to liposomes comprising adenosine phosphates.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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 21-30 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 21 recites the following, as of the 2nd through the 4th line of the claim.
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This would appear to indicate that a liposome made from sphingomyelin but lacking DMPG and lacking DMPC would meet the claimed requirements. Claim 27 also appears to indicate that this is the case, as the scope of claim 27 appears to include a composition comprising 100% sphingomyelin and 0% DMPC and/or DMPG.
However, elsewhere in claim 21, the claim recites the following:
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This would appear to indicate that a composition comprising only sphingomyelin and lacking DMPC and lacking DMPG would not be within the claim scope.
As such, it is unclear whether a composition comprising sphingomyelin but lacking DMPC and lacking DMPG is within the scope of claim 21.
For the purposes of examination under prior art, the examiner will proceed with the understanding that claim 21 requires sphingomyelin and at least one of DMPC and/or DMPG.
Claim Rejections - 35 USC § 103 – Obviousness
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.
Claims 1, 6-22 and 24-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corciulo et al. (Nature Communications, 8:15019, published 11 May 2017, pages 1-13) in view of Barenholz et al. (US 2010/0098749 A1).
Corciulo et al. (hereafter referred to as Corciulo) is drawn to adenosine in order to maintain cartilage homeostasis and to inhibit osteoarthritis progression, as of Corciulo, page 1, title and abstract. Corciulo teaches the following, as of Corciulo, page 1, abstract, relevant text reproduced below, with specific terms highlighted by the examiner.
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Corciulo also teaches the effect of liposomal adenosine as of page 7, figure 5, wherein relevant portions of figure 5D are reproduced below.
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The term “liposome” above refers to an empty liposome, and the term “Lipo-ADE” refers to a liposome encapsulating adenosine. As such, Corciulo is understood to teach beneficial effects of liposomal adenosine in treating or preventing the progression of osteoarthritis.
Corciulo differs from the claimed invention because the liposomes of Corciulo are made from phosphatidylcholine and cholesterol and do not include sphingomyelin, as of Corciulo, page 11, left column, section entitled “liposome preparation.”
Barenholz et al. (hereafter referred to as Barenholz) is drawn to joint lubrication and prevention of cartilage wear and tear by using liposomes, as of Barenholz, title and abstract, and mentions osteoarthritis specifically as of paragraph 0018. The liposome of Barenholz includes a phospholipid and a sphingolipid, as of Barenholz, abstract. Barenholz teaches sphingomyelin, as of Barenholz, paragraphs 0088, claim 9 of Barenholz, and claim 23 of Barenholz. Barenholz also teaches a sphingomyelin by its abbreviation “SM” as of Barenholz, paragraphs 0065-0068 and 0087-0088. Barenholz teaches DMPC (dimyristoyl phosphatidylcholine) at many locations in the reference including but not limited to paragraphs 0090 and 0067. Barenholz teaches DMPG as of paragraph 0067 and phosphatidylglycerols generally as of paragraph 0065.
Barenholz does not teach adenosine.
It would have been prima facie obvious for one of ordinary skill in the art to have delivered the adenosine of Corciulo using the liposome of Barenholz. Corciulo is drawn to the therapeutic effect of adenosine in treating or preventing the progression of osteoarthritis. Corciulo also teaches administering the adenosine in the form of a liposome. Barenholz is drawn to a specific type of liposome that is useful for joint lubrication and prevention of cartilage wear and appears useful in the treatment and/or management of osteoarthritis, even in the absence of an additional active agent. As such, the skilled artisan would have been motivated to have administered the adenosine of Corciulo in the liposome of Barenholz for predictable treatment of osteoarthritis via both the therapeutic effect of adenosine described by Corciulo and that described by Barenholz with a reasonable expectation of success. The skilled artisan would have expected that this combination would have improved upon the therapeutic effects taught by Corciulo because osteoarthritis would have been treated both by the therapeutic mechanism taught by Corciulo and the therapeutic mechanism taught by Barenholz.
As to claim 1, the claims require an injectable formulation of liposomes combined with saline. Corciulo teaches the following on page 11, left column, section entitled “Liposome preparation”, reproduced below.
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As such, the liposomes of Corciulo appear to include saline. Corciulo also teaches intra-articular injection as of the abstract, resulting in the composition of Corciulo being injectable.
As to part (a) of claim 1, Barenholz teaches liposomes sized from about 0.3 µm (300 nm) to about 8 µm, as of Barenholz, paragraph 0037. This is within the claimed size range.
As to part (b) of claim 1, the claim requires that adenosine be encapsulated in the aqueous compartment of the liposome. The skilled artisan would have expected that the composition of Corciulo, either by itself or in view of Barenholz, would have encapsulated adenosine in the aqueous compartment. This is because adenosine is a hydrophilic drug; therefore, it would have been present in the aqueous compartment of the liposome rather than as part of the lipid bilayer.
As to claim 1, the claim requires specific amounts of sphingomyelin, DMPC, and DMPG, wherein said amount are 70% to 100% sphingomyelin by mass. As best understood by the examiner, while Barenholz teaches all of these lipids, Barenholz does not appear to teach these lipids together in the recited amounts. Nevertheless, generally, differences in concentration between the prior art and claimed invention will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, no evidence of criticality of concentrations has been presented on the record at this point in prosecution. Additionally, where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of a liposome comprising sphingomyelin, DMPC, and DMPG to treat osteoarthritis has been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have discovered optimum or workable ranges of amounts of these ingredients by routine experimentation.
As to claim 1, the claim requires adenosine having a concentration of from 1 mg/mL to 3 mg/mL. As best understood by the examiner, the concentration of Corciulo is 2.7 mg/mL. Support for this is provided as of the declaration submitted to the file record on 3 September 2024.
As to claim 6, Corciulo teaches that the liposomal formulation of adenosine was done to prolong the half-life of adenosine, as of Corciulo, page 6, top paragraph. While Corciulo does not appear to teach a specific numerical value of the half-life of adenosine, the skilled artisan would have been motivated to have modified its half-life to have been within the claimed time period.
As to claim 7, Corciulo teaches saline, glycerin, and water, as of Corciulo, page 11, section entitled “liposome preparation”, reproduced above. These are all understood to be excipients.
As to claims 8-9, Barenholz teaches both DMPC and DMPG, as of Barenholz, paragraphs 0065-0068. While Barenholz does not appear to teach a specific ratio of these components, Barenholz does teach modifying the ratio of phosphatidylcholine (e.g. DMPC), phosphatidylglycerol (e.g. DMPG), and sphingomyelin components of the liposome to achieve a specific packing parameter range, as of Barenholz, paragraph 0066. Where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of a liposome comprising phosphatidylcholine and phosphatidylglycerol, including DMPC and DMPG, for treating osteoarthritis, has been taught by Barenholz. As such, it would not have been inventive for the skilled artisan to have determined the optimum or workable ranges of these components by routine experimentation. In addition, it would have been obvious to have optimized result-effective variables. See MPEP 2144.05(II)(B). In this case, the ratio of phosphatidylcholine to phosphatidylglycerol components appear to be result-effective at least because affects the result of the packing parameter of the liposome, as of Barenholz, paragraph 0066.
As to claim 10, Barenholz teaches 35-140 mM of total lipid, as of Barenholz, paragraph 0041. The examiner has converted this to lipid in mg/mL, using an approximate value of 700 Daltons for the molecular weight of the lipid.
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This amount is slightly higher than the amount required by the instant claims. Nevertheless, generally, differences in concentration between the claimed invention and prior art will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, there does not appear to be evidence that total lipid concentration is critical. Additionally, where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of a liposome comprising lipids has been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have discovered the optimum or workable ranges of lipid concentration by routine experimentation.
As to claims 11-12, Barenholz teaches liposomes sized 0.8-3.5 µm in diameter, as of Barenholz, paragraph 0052. This is within the claimed range.
As to claim 13, Barenholz teaches a phase transition temperature of about 20-39ºC, as of Barenholz, abstract. This overlaps with the required temperature range of 35-45ºC. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claims 14-17, Corciulo teaches intra-articular injection, as of Corciulo, page 1, abstract. Barenholz also teaches intra-articular injection, as of Barenholz, paragraph 0039. Additionally, Corciulo teaches concentrations of adenosine of about 1250 nanomolar as amounts that have been released, as of Corciulo, page 5, figure 3C. The examiner has shown the following conversion to convert this to mg/mL, assuming a molecular weight of about 267.25 g/mol for adenosine and a density of 1 g/mL.
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The measurement of 0.0003 ng/mL appears to be the amount of adenosine being released at a given time. As best understood by the examiner, the skilled artisan would have understood that the above-indicated release rate would have resulted in release in the time period of one second to one hour or one minute to ten minutes after administration to a joint.
As to claims 18-19, Barenholz teaches liposomes sized 0.8-3.5 µm in diameter, as of Barenholz, paragraph 0052. This size range overlaps with the claimed size range. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 20, the claim requires specific amounts of sphingomyelin, DMPC, and DMPG. As best understood by the examiner, while Barenholz teaches all of these lipids, Barenholz does not appear to teach these lipids together in the recited amounts. Nevertheless, generally, differences in concentration between the prior art and claimed invention will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, no evidence of criticality of concentrations has been presented on the record at this point in prosecution. Additionally, where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of a liposome comprising sphingomyelin, DMPC, and DMPG to treat osteoarthritis has been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have discovered optimum or workable ranges of amounts of these ingredients by routine experimentation.
As to claim 21, this is a newly added independent claim. This claim is understood to be a product-by-process claim drawn to a liposome prepared by a particular method. The prepared liposome comprises sphingomyelin in an amount of less than 100% of all the lipids, and also comprises DMPC, DMPG, or DMPC and DMPG together, as well as adenosine in a particular concentration. Barenholz teaches a sphingomyelin by its abbreviation “SM” as of Barenholz, paragraphs 0065-0068 and 0087-0088. Barenholz teaches DMPC (dimyristoyl phosphatidylcholine) at many locations in the reference including but not limited to paragraphs 0090 and 0067. Barenholz teaches DMPG as of paragraph 0067 and phosphatidylglycerols generally as of paragraph 0065. Corciulo teaches adenosine in a liposome. Product-by-process claims are not limited to the recited steps, only to the structure implied by the steps. See MPEP 2113(I). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing a nonobvious difference between the claimed product and the prior art product. See MPEP 2113(II). It is the examiner’s position that the subject matter of claim 21 is prima facie obvious for essentially the same reason as is the case regarding claim 1. Additionally, the prior art teaches all of the elements required by the claim.
As to claim 21, the claim requires adenosine having a concentration of from 0.3 mg/mL to 3 mg/mL. As best understood by the examiner, the concentration of Corciulo is 2.7 mg/mL. Support for this is provided as of the declaration submitted to the file record on 3 September 2024.
As to claim 22, the claim requires adenosine having a concentration of from 0.3 mg/mL to 3 mg/mL. As best understood by the examiner, the concentration of Corciulo is 2.7 mg/mL. Support for this is provided as of the declaration submitted to the file record on 3 September 2024.
As to claims 24-25, Barenholz teaches both DMPC and DMPG, as of Barenholz, paragraphs 0065-0068. While Barenholz does not appear to teach a specific ratio of these components, Barenholz does teach modifying the ratio of phosphatidylcholine (e.g. DMPC), phosphatidylglycerol (e.g. DMPG), and sphingomyelin components of the liposome to achieve a specific packing parameter range, as of Barenholz, paragraph 0066. Where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of a liposome comprising phosphatidylcholine and phosphatidylglycerol, including DMPC and DMPG, for treating osteoarthritis, has been taught by Barenholz. As such, it would not have been inventive for the skilled artisan to have determined the optimum or workable ranges of these components by routine experimentation. In addition, it would have been obvious to have optimized result-effective variables. See MPEP 2144.05(II)(B). In this case, the ratio of phosphatidylcholine to phosphatidylglycerol components appear to be result-effective at least because affects the result of the packing parameter of the liposome, as of Barenholz, paragraph 0066.
As to claim 27, the claim requires specific amounts of sphingomyelin, DMPC, and DMPG, wherein said amount are 70% to 100% sphingomyelin by mass. As best understood by the examiner, while Barenholz teaches all of these lipids, Barenholz does not appear to teach these lipids together in the recited amounts. Nevertheless, generally, differences in concentration between the prior art and claimed invention will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, no evidence of criticality of concentrations has been presented on the record at this point in prosecution. Additionally, where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of a liposome comprising sphingomyelin, DMPC, and DMPG to treat osteoarthritis has been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have discovered optimum or workable ranges of amounts of these ingredients by routine experimentation.
As to claims 28-29, these claims are rejected for essentially the same reason that claims 24-25 are rejected.
As to claim 30, Barenholz teaches 35-140 mM of total lipid, as of Barenholz, paragraph 0041. The examiner has converted this to lipid in mg/mL, using an approximate value of 700 Daltons for the molecular weight of the lipid.
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This amount is slightly higher than the amount required by the instant claims. Nevertheless, generally, differences in concentration between the claimed invention and prior art will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, there does not appear to be evidence that total lipid concentration is critical. Additionally, where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of a liposome comprising lipids has been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have discovered the optimum or workable ranges of lipid concentration by routine experimentation.
Response to Declaration Under 37 C.F.R. 1.132
A declaration under 37 C.F.R. 1.132 has been submitted as of applicant’s response on 10 February 2025 (hereafter referred to as the latest declaration). The examiner has addressed the data presented therein below.
Note Regarding Formulation Nomenclature: Prior to reviewing the subject matter of the slides provided in the latest declaration, the examiner notes that the data provided by declarant refers to formulations named “RgnA01”, “RgnA09”, and “RgnA10.” As best understood by the examiner, RgnA01 is similar to the composition of Corciulo, as of the instant specification on page 17, paragraph 0072. In this case, the examiner understands the liposome of Corciulo to have 0% sphingomyelin and 2.7 mg/mL adenosine, as of paragraph #9 of the declaration.
RgnA09 and RgnA10 (wherein RgnA10 is not actually discussed in the latest declaration but was discussed in the specification) have concentrations of components set forth below, as of the table on page 18 of the specification, which is reproduced below.
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As such, RgnA09 has 75% sphingomyelin, and RgnA10 has 100% sphingomyelin. These formulations can be prepared with varying amounts of adenosine.
Overview of Most Recent Declaration: The most recent declaration presents various slides containing figures. All of these figures are line graphs, whose y-axis is explained below, as of paragraph #6 of the most recent declaration, which is reproduced below.
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As such, a lower value of the differences in the joint size is superior to a higher value thereof, with a value of 1 mm or less considered essentially normal.
Slide 1: Slide 1 from the latest declaration has been reproduced below.
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It is the examiner’s position that the above-reproduced figure shows that RgnA09 having 3 mg/mL adenosine and RgnA01 having 2.7 mg/mL adenosine have superior reduction in joint size as compared with RgnA09 at 1 mg/mL or the controls. This would not have been an unexpected or surprising result because the skilled artisan would have expected a higher dose of adenosine to have been more effective than a lower dose of adenosine. As such, slide 1 does not appear to show unexpected results.
Slide 2: Slide 2 of the latest declaration compares RgnA09 at 1 mg/mL adenosine to RgnA09 at 3 mg/mL adenosine. As best understood by the examiner, both formulations are within the claim scope. As such, this figure does not show comparative testing between the claimed formulation and a comparative or prior art formulation and is therefore not probative of non-obviousness.
Slides 3, 5, and 6: Slides 3, 5, and 6 compare RgnA09 at 3 mg/mL adenosine to RgnA01, which is the comparative example with 2.7 mg/mL adenosine. The examiner clarifies that RgnA09, being the claimed invention, is a liposome comprising sphingomyelin, whereas RgnA01 is a liposome lacking sphingomyelin and is therefore outside the claim scope. As best understood by the examiner, the data shows that RgnA09 at 3 mg/mL appears to have significant improvement as compared with RgnA01 at 10-40 days. As best understood by the examiner, this would appear to be unlikely to be caused by the small difference in adenosine dose between 2.7 mg/mL in RgnA01 and 3 mg/mL in RgnA09. As such, the data presented herein would appear to show that the claimed composition has superior results.
Nevertheless, unexpected results must be commensurate in scope with the claimed invention. See MPEP 716.02(d). In this case, the data would appear to be commensurate in scope only with 3 mg/mL adenosine, not with the full scope of 1-3 mg/mL adenosine. This determination is made at least in view of other slides such as slide 1 which would appear to show that RgnA09 at 1 mg/mL does not provide unexpectedly superior results.
The examiner clarifies that the position taken herein is consistent with the position taken on pages 19-20 of the prior office action mailed on 9 September 2024 not to reject claim 5 over prior art. This position is also consistent with the examiner’s determination of allowability in parent application 17/601,032.
Slide 4: Slide 4 has been reproduced below.
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This slide compares the claimed invention at 1 mg/mL adenosine (RgnA09) with the comparative example (RgnA01), which has 2.7 mg/mL adenosine. The above-reproduced data appears to show that the comparative example (RgnA01) has superior results as compared with the claimed invention due to the lower joint size difference at all time points measured for the comparative example as compared with the claimed invention at 1 mg/mL adenosine. While day 40 shows similar results of the inventive and comparative example, day 50 appears to show an extremely significant difference between the claimed invention and comparative example, and day 30 also shows a significant difference between the claimed invention and comparative example. As such, nothing in the above-reproduced data appears to show that the claimed invention at 1 mg/mL adenosine provides similar results as compared with the comparative example at 2.7 mg/mL adenosine despite a lower amount of active agent. Therefore, nothing from slide 4 of the declaration would appear to be probative of non-obviousness.
Response to Arguments Regarding Obviousness Rejections
Applicant has presented arguments regarding the previously applied obviousness rejections, as of page 6 of applicant’s response on 4 September 2025. Applicant argues that the claims are patentable for the reasons set forth in the declaration under 37 C.F.R. 1.132. The examiner disagrees. The declaration under 37 C.F.R. 1.132 is insufficient to overcome the applied rejections for the reasons set forth above.
Claims 5 and 23 Are Not Rejected Over Prior Art
In the prior office action mailed on 1 May 2024, claim 5 was rejected as obvious over the combination of Corciulo et al. (Nature Communications, 8:15019, published 11 May 2017, pages 1-13) in view of Barenholz et al. (US 2010/0098749 A1). That rejection has been withdrawn. Specifically, it is the examiner’s position that data in figure 9 of the instant application show the unexpected superiority of the subject matter of claims 5 and 23 over the prior art. The examiner’s reasons for taking this position are essentially the same as the reasons taken by the examiner for allowing the claims in parent application 17/601,032; see the reasons for allowance set forth on 25 October 2022 in the prior ‘032 application. Claim 23 is not rejected over prior art for similar reasons.
Claim 5 is not in condition for allowance because, while not rejected over prior art, it is still rejected on the grounds of non-statutory double patenting. See the rejections below. Claim 23 is not in condition for allowance because, while not rejected over prior art, it is still rejected on the grounds of 35 U.S.C. 112(b) and non-statutory double patenting.
Non-Statutory 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 1 and 5-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,607,386. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a liposome encapsulating adenosine having a concentration of 1-3 mg/mL, wherein a significant amount of the total liposome lipids is composed of sphingomyelin.
The conflicting claims are drawn to a liposome encapsulating adenosine, wherein a significant amount of the total liposome lipids is composed of sphingomyelin. The conflicting claims recite the amount of adenosine. In the conflicting claims, adenosine is present at 3 mg/mL.
The instant and conflicting claims differ because conflicting claim 1 recites 3 mg/mL adenosine, whereas instant claim 1 recites 1-3 mg/mL adenosine. Nevertheless, the subject matter of the conflicting claims appears to be within the scope of that of the instant claims. As such, the subject matter of the conflicting claims effectively anticipates that of the instant claims, resulting in a prima facie case of anticipatory-type non-statutory double patenting.
Claims 1 and 5-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/465,726 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a liposome encapsulating adenosine, wherein a significant amount of the total liposome lipids is composed of sphingomyelin. The instant claims recite 1-3 mg/mL adenosine.
The copending claims are drawn to a liposome encapsulating adenosine, wherein a significant amount of the total liposome lipids is composed of sphingomyelin. Copending claim 7 recites 0.1 to 4 mg/mL adenosine.
The instant and copending claims differ because the copending claim 1 recites a particle size that is not recited by instant claim 1. Nevertheless, the subject matter of copending claim 1 appears to be within the scope of that of instant claim 1. As such, the subject matter of the copending claims effectively anticipates that of the instant claims, resulting in a prima facie case of anticipatory-type non-statutory double patenting.
The instant and copending claims also differ because copending claim 7 recites 0.1 to 4 mg/mL adenosine, whereas the instant claims recite 1 to 3 mg/mL adenosine. Nevertheless, this overlap results in a prima facie case of obviousness. See MPEP 2144.05(I).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments Regarding Double Patenting
In applicant’s response, pages 6-7, applicant argues that claim 1 is patentable over the cited references. Applicant does not appear to have presented arguments in support of this position other than an assertion that claim 1 is patentable over the cited references. In view of this, the double patenting rejections have been maintained by the examiner.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612