DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.11
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 29, 2024 has been entered.
Applicants' arguments, filed November 29, 2024, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Request for Rejoinder
Applicants request rejoinder of claim 41 as the methods of claim 1 and 41 have the same active steps with an identical solution and relate to the same patentable technical feature. Reference is also made to a previous response indicating that two processes cannot be rejoined.
These arguments are unpersuasive. The instant case is a National Stage Entry with restriction practice governed by the lack of unity standard. The common technical feature between claims 1 and 41 does not represent a special technical feature in view of the prior art rejections set forth below. Therefore the restriction between group I (claim 1 and the claims depending from claim 1) and group III (claim 41) is maintained as the common technical feature is not a special technical feature.
Comments and Notes
The status identifier for claim 58 in the response filed November 29, 2024 is improper as claim 58 is no longer new as it was added in the April 19, 2024 claim set. Failure to properly format claim amendments including proper claim status identifiers can result in the mailing of a Notice of Non-Compliant Amendment so every effort should be made to properly format future claim amendments.
Since claim 1 as currently amended only contains a single polymer material that is identified as a non-crosslinked polymer, all subsequent references in claim 1 and various dependent claims to “the polymer” can only refer to the non-crosslinked polymer portion of the composition. For exact antecedent basis, it is respectfully suggested that “the non-crosslinked polymer” be used rather simply “the polymer”.
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. 365(c) 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. PCT/IL2015/050987, 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. The negative proviso excluding the presence of an antimicrobial agent, was added as new claim 51 in the claim amendments filed April 2, 2017 and that subject matter is not disclosed in the specification of PCT/IL2015/050987. Therefore the effective filing date of all of the claims under examination is April 2, 2017, the filing date of Application No. 15/516,407.
If Applicant is in disagreement with the Examiner regarding support for the priority, Applicant is respectfully requested to point to page and line number wherein support may be found for this negative proviso.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: as discussed above, the specification does not support that the composition used in the method of inhibiting biofilm formulation on a surface with a substrate using the composition as recited in claim 1 that is devoid of an antimicrobial agent. Appropriate correction is required.
Claim Rejections - 35 USC § 112 – New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4, 8, 11, 28, 52, 54, 57 and 58 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
The Examiner was unable to locate support in the disclosure as originally filed for a two-step method as required by claim 1 with one step of contacting the substrate any composition containing liposomes and HPMC having a molecular weight of 5 kDa or 10 MDa and a second step in which a solution comprising said liposomes is used to rinse and/or immerse the contact lens. That the contacting step can comprise rinsing and/or immersing the contact lens substrate is supported by ¶ [0044] of the PGPub of the instant application but the phrasing of claim 1 requires two separate steps – contacting and rinsing/immersing and the materials used need not be the same as the contacting step is carried out with a composition comprising liposomes and HPMC having a molecular weight of 5 kDa or 10 MDa while the rinsing/immersing step is a solution of liposomes and can contain but is not required to have a polymer such as HPMS. There was no indication that the steps can be repeated such that one could be the broad ‘contacting’ step with another more specific step of rinsing/immersion and even if so, that the materials used in each step need not be the same.
If Applicant is in disagreement with the Examiner regarding support for the claimed subject, Applicant is respectfully requested to point to page and line number wherein support may be found for the instant invention.
The dependent claims fall therewith.
Claim Rejections - 35 USC § 112 – Indefiniteness
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4, 8, 11, 28, 52, 54, 57 and 58 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.
Amongst the limitations in claim 1 is that “a concentration of phospholipids in said liposomes in said composition is in a range of from 1 mM to 150 mM” (emphasis added) is unclear. The units of molarity (M) are moles per liter, and liter is appropriate units for solution as a whole but that is not how this limitation is written. It appears that this claim limitation compares the moles of phospholipid to the volume the liposomes but it is not clear if that volume includes the phospholipid walls that don’t actually contain liquid or just the total volume of solution present inside the totality of all the liposomes present in the composition? Are only the phospholipids that form part of the liposomes included in this calculation and phospholipid molecules that are free in solution or present as a film, for example, not part of the liposomes excluded from this calculation?
Please clarify.
The dependent claims fall therewith.
Claim 54 is 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 54 references multiple weight percents as the term is present in the plural form but only recites one weight percent, the amount of liposomes that are small unilamellar vesicles recited in the claim. It cannot be determined in the plural form “percents” was an error and only a single weight percent is required or if the claim is incomplete and other limitations defined by weight percent were omitted from the claim.
The term “small” is a relative term which renders the claim indefinite. The term “small” or “small unilamellar vesicles” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. One of ordinary skill in the art is not apprised of the required size of the unilamellar vesicles that must be present in the composition to fall within the scope of claim 54 as while this may be a term of art, there is not a uniform definition of the size range of vesicles that are considered small.
Please clarify.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 4, 8, 11, 28, 52, 54 and 58 were rejected under 35 U.S.C. 103 as being unpatentable over Sullivan et al. (US 2014/0099343) in view of White et al. (Biomaterials, 2011), Saavedra et al. (US 2006/0014013) and Gram et al. (WO 2003/092382). This rejection is MAINTAINED for the reasons of record set forth herein.
Sullivan et al. discloses an ophthalmic device and method of use thereof for an individual wearing an ophthalmic lens, which reads on a contact lens, to increase ocular surface bound lubrication with an ophthalmic lens and a sacrificial mechanism disposed on the lens (whole document, e.g., abstract). The compositions can be used to establish a sacrificial mechanism to prevent protein or lipid adsorption on the lens surface amongst other features and the replenishment of the hyaluronic acid and/or phospholipids can be in the form of artificial tear drops, rewetting solutions, contact lens cleaning products, an overnight incubation or other contact lens care products (¶ [0046]). The lubricating composition can comprise a gel-forming agent and/or a surfactant (¶ [0021]) and can further comprise additional ingredients such as those disclosed in ¶ [0022] including demulcents such as hypromellose (hydroxypropyl methyl cellulose, HPMC). The gel-forming or surfactant compositions can further comprise other ophthalmiac lens care compounds that may be suspended in phosphate buffered saline, reading on an aqueous carrier, or an osmotically balanced salt solution of tear electrolytes (¶ [0025]). The gel forming agent or composition can comprise hyaluronic acid, hyaluronate, one or more surface active phospholipids such as L-O-dipalmitoylphosphatidyl choline, phosphatidylethanolamine, and sphingomyelin (¶ [0017]). Therapeutically effective concentrations of hyaluronic acid or sodium hyaluronate range from 10 - 100,000 µg/mL, preferably 500-5,000 mg/mL while therapeutically effective concentration of the surface active phospholipids range from 10 - 10,000 µg g/mL (¶ [0085]). Hyaluronate is capable of forming a hydrogel in an aqueous carrier. While human body temperature is typically referenced as 37°C, the surface of the eye is exposed to ambient air and is likely at temperature lower than 37°C. Additional uses such as contact lens cleaning products, an overnight incubation or other contact lens care products are most often used at room temperature which is typically well below 37°C and can be repeated multiple times are disclosed (¶ [0046]). An overnight storage solution is used to store the lens overnight, to clean the lens prior to storage and/or rinse the lens after storage and therefore carrying out the contacting step at temperatures below 37°C is taught by Sullivan et al.
The molecular weight of the HPMC is not disclosed.
White et al. discloses an extended, controlled release coating of 120 kDa HPMC for silicon contact lenses to alleviate contact lens induced dry eye (CLIDE) rather than re-wetting via eye drops (whole document, e.g., abstract). HPMC is a common re-wetting agent and rheology modifier used in over the counter eye drops (p 5699, col 1, ¶ 6). Phospholipids can also be covalently attached to lenses to increase the ocular biotolerance and decrease the disruption of the tear film (p 5699, col 1, ¶ 1).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use an HPMC having a molecular weight of 120 kDa in the compositions disclosed by Sullivan et al. that can further comprise a hydrogel-forming material such as hyaluronate. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because HPMC is disclosed by Sullivan et al. as part of a sacrificial mechanism on the contact lens and White et al. disclosed that 120kDa HPMC can form a layer on contact lens that in addition to the functions disclosed by Sullivan et al. can also alleviate contact lens induced dry eye. One of ordinary skill in the art can readily select from various ingredients that have functions that are known for inclusion in contact lens cleaning products, an overnight incubation or other contact lens care products as taught by Sullivan et al. There is no evidence of record of unexpected results based on the claimed composition that is also reasonably commensurate in scope with the instant claims.
That liposomes such are present in the composition and adhere to substrates with the phospholipids being present as unilamellar vesicles in the composition is not disclosed.
Saavedra et al. discloses mono-, bi- or multi-layer lipid membranes stabilized on a solid support (¶ [0003]). Such supported lipid layers can self-assemble by fusion of fluid, unilamellar vesicles (¶ [0010]). SUVs spontaneously unroll to produce an extended, continuous lipid monolayer or bilayer in a buffered aqueous solution or deionized water (¶ [0054]). Vesicle fusion to solid supports is a well-documented and commonly used practice to form substrate supported lipid bilayer even though the subtle balance of factors including van der Waals, electrostatic, hydration and steric forces that play a role in the process are poorly understood (¶ [0061]). The lipid used in the method can phospholipids such as phosphatidylcholine (e.g., claim 7). The concentration of suspended vesicles in the aqueous solution plays a role in the kinetics of bilayer formation (¶ [0061]). The lipid concentration is in the range of from 0.01 mg/L to 5 mg/mL with 0.5 mg/mL being a preferred value (¶ [0057]). In order to control the bilayer fluidity, the main phase transition temperature of the lipid can be controlled through lipid chain tail length selection from 14 – 22 carbon atoms and the extent and location of unsaturation and/or branching in the lipid tail(s) as shown in Figure 5 (¶ [0056]). Lipids were fused to the solid substrate in the examples at a temperature equal to or greater than their respective main phase transition temperature for at least 10 minutes (¶ [0133]).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate prepare a composition comprising SUVs as disclosed by Saavedra et al. in the composition of Sullivan et al. and White et al. as a lipid structure whose main phase transition temperature is equal to or greater than the temperature at which the contracting and rinsing and/or immersing takes place. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Saavedra et al. discloses that such structures can be prepared using phospholipids such as phosphatidylcholine and result in the self-assembly of lipid layers on a substrate which as taught by Sullivan et al., can be a contact lens.
Features such as melting point (main phase transition temperature) of the liposomes and the change in surface adsorption on the contact lens substrate in the presence and absence of the claimed composition is determined by the composition itself. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 The main phase transition temperature can be altered by lipid selection and should be considered relative to the temperature at which substrate contacting and rinsing and/or immersing takes place so that the substrate can be coated with the lipids. There is currently no persuasive evidence of record that use of the compositions rendered obvious by the applied prior art do not have the features which are relied upon in the claims and/or that such materials are not rendered obvious by the teachings of the applied prior art and the knowledge of one of ordinary skill in the art.
None of the above references explicitly disclose that materials and coatings as taught in the applied prior art reduce biofilm formation on surfaces such as contact lens.
Gram et al. disclose that there are many methods that have been developed to prevent microbial adhesion and biofilm formation (p 2, ln 34 – p 3, ln 3). One such method is coating of surfaces with detergents, wetting agents, and other surface active compounds will cause a decrease in in vitro bacterial adsorption to surfaces (i.e. biofilm formation) with approx. 1 log unit (90% reduction; p 3, ln 27 – 28).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention would have reasonably expected that contacting contact lens contacted with and rinsed and/or immersed a composition as in Sullivan et al., White et al. and Saavedra et al. would reduce or inhibit biofilm formation. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected such an effect as these materials can form layers on the surface of a substrate such as a contact lens and the presence of such materials will have multiple effects, including decreased surface adsorption of bacteria.
Applicants traverse the rejection on the grounds that detailed argumentation has been provided demonstrating that the claimed invention could not have been arrived at without an inventive activity and without hindsight as multiple selections for which there is no guidance of motivation is given in the cited documents. It has been explained many times that the claims read on specific liposomes with a specific TM that together with a specific polymer show synergistic effect, showing secondary consideration reasonably commensurate in scope with the claims.
These arguments are unpersuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton (MPEP 2141(II)(C). There need not be an explicit teaching, suggestion or motivation given in the applied prior art to select phosphatidylcholine, for example, as part of the liposomes or to include ingredients that are explicitly taught in the applied prior art as suitable for inclusion in compositions such as contact lens cleaning products, an overnight incubation or other contact lens care products. The claims are slightly specific in that HPMC is required to be present but can have a molecular weight ranging from 5 kDa to 10 MDa. Liposomes comprised of phosphatidylcholine, a genus of compounds, at some concentration range with a melting point lower than 36°C are required but this encompasses a large number of liposomes and even possible structures as exemplified by dependent claim 54. The data of record from the specification is very limited and while HPMC is used is appears to only have been a single molecular weight within an extremely larger range, only one phosphatidylcholine is used in the comparisons. There is no discussion of what the expected results would be and even if a synergistic effect is shown, synergism can be an expected result (see MPEP 716,02 et seq. for a complete discussion of allegations of unexpected results). The comparisons don’t clearly set forth the concentration of the phospholipid in said liposomes in said compositions or the melting temperature of the liposomes. The comparisons do not make use of HPMC materials that span the claimed molecular weight range. While several different types of contact lens material were used, they were all hydrogels (only instant claim 4 requires a hydrogel contact lens substrate). When all of these factors are taken into consideration, even if persuasive evidence of unexpected results was of record, such evidence would not be reasonably commensurate in scope with the claims.
Applicants also cite portions from the specification discussing results for HEMA hydrogels loaded with HSPC liposomes in a solid phase compared to DMPC liposomes that were in a solid phase and that some embodiments exhibit superior anti-biofouling effects compared to solid phase liposomes. Claim 1 specifically characterizes the liposomes as featuring Tm lower than the contacting temperature and hence liquid with figure 1 showing the superiority of liquid phase liposomes. Figure 10 clearly demonstrates the synergistic effect provided by liposomes with a Tm as claimed and HPMC. HSPC and DMPC are different from one another with the melting temperature clearly correlating with the phase of the liposomes.
These arguments are unpersuasive. While claim 1 recites the melting temperature of the liposomes, there is no limitation as to the contacting temperature and/or rinsing/immersing steps of claim 1. Only dependent claim 58 recites a contacting temperature of below 37°C, which could be 36.9°C for example and even if the liposomes had a Tm of 36°C, the liposomes would be in the solid phase under these conditions. The liposomes only need to comprise any amount of a phospholipid such as DMPC and the liposomes can contain any other constituents that will also affect the melting point of the resulting liposomes. As discussed above, with no explanation as to the expected results and more data for more formulations and/or narrowing claim amendments, the evidence in support of the alleged unexpected results is unpersuasive and does not outweigh the prima facie case of obviousness.
Applicants also argue that a person skilled in the art is motivated to put together pieces that provide a desired, known outcome but such a person could not have known which pieces to select and how to fit them together to arrive at the claimed invention. No identification as to where in these documents guidance to select these pieces with being affected by hindsight has been given. Sullivan is concerned with a lubricating composition and at most describe a combination of hyaluronic and a surfactant which can be a phospholipid with no mention in the cited section of HPMC or liposomes. The inclusion of a surfactant and ophthalmically acceptable agents is optional. Even if selected, why would the selection of HPMC be motivated out of the dozens of agents also recited in these paragraphs? Sullivan also does not teach liposomes and the evidence of record has not established that the Sullivan’s compositions necessarily comprise liposomes. The MPEP requires that the combination of elements known in art with no change in their function that yields nothing more than predictable results to be obvious and a reason to combine the elements in the way claimed must be identified and if these findings cannot be made, this rationale cannot be used to support a conclusion of obviousness. Sullivan provides no reason to combine surface active phospholipids with HPMC. White and Grahm [sic] do not discuss liposomes and thus fail to remedy the deficiencies of Sullivan et al.
These arguments are unpersuasive. There need not be an explicit teaching, suggestion or motivation in the applied art and that various ingredients are taught as optional ingredients does not rise to the level of teaching away from selecting a specifically disclosed material such as HPMC or hyaluronate. Particularly when the teachings of the other applied references such as White et al. as to effects of HPMC incorporated into contact lens are taken into account, one of ordinary skill in the art would not even be blindly selecting ingredients that are specifically mentioned in Sullivan. The person of ordinary skill in the art would reasonably expect success that a variety of formulations can be prepared based on the teachings of the applied prior art that can be contacted with and also used to rinse/immerse a contact lens as required by the active steps of the instant claims. Gram et al. would even lead one of ordinary skill in the art to reasonably expect beneficial effects on material adsorption/biofilm formation to the contact lens in the presence of wetting agents (HPMC is taught as wetting agent) and surfactants (and phospholipids are surfactants) as required by the preamble of the instant claim. The rejection does not suggest that Sullivan, White et al. or Gram et al. teaches liposomes as Saavedra et al. is relied on to teach this feature and there is no discussion of this reference in the remarks. 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). White et al. discloses the effects of HPMC in combination with contact lenses, reinforcing the teachings of Sullivan et al. of HPMC as a possible demulcent in the disclosed compositions. Saavedra et al. discloses that SUVs comprising phospholipids such as those disclosed by Sullivan et al. can self-assemble on surface that can provide protein resistance to such surfaces. The evidence of record has not established that the claimed composition demonstrates unexpected results.
As to the Tm of the liposomes, the Examiner has not explained where liposomes with the same chemical and structural components are taught. The melting point does not merely depend on the chemical and structural features but on the arrangement of molecules and this requirement is not related to claimed subject matter. The superior and synergistic effects are again references.
These arguments are unpersuasive. Liposomes, whose definition was provided by Applicants in the remarks from the instant specification, have a required structure as given in the cited definition. Phosphatidylcholines such as DMPC are required by the claims and a more particularly liposomal structure of small unilamellar vesicles are required by dependent claim 54 that is not rejected over this combination of prior art. No other limitations on the “arrangement of molecules” are seen in the claims. Applicants are invited to further explain what such molecular arrangements are and/or how such limitations are present in the instant claims.
Claim(s) 1, 4, 8, 11, 28, 52, 54, 57 and 58 was rejected under 35 U.S.C. 103 as being unpatentable over Sullivan et al., White et al., Saavedra et al. and Gram et al. as applied to claims 1, 4, 8, 11, 28, 52, 54 and 58 above, and further in view of Pruitt et al. (US 2010/0140114) and Iwasaki et al. (J Biomaterials Sci, 1999).
Sullivan et al., White et al., Gram et al. and Saavedra et al. are discussed above.
The use of phosphatidylcholines such as dipalmitoylphosphatidyl choline is disclosed but not the use of 1,2-dimyristoyl-sn-glycero-3-phosphocholine (DMPC).
Pruitt et al. discloses soft hydrogel contact lens that are capable of delivering a hydrophobic comfort agent into the eye of the user (whole document, e.g., abstract). The contact lens comprises a polymeric matrix and a hydrophobic comfort agent that is not covalently linked to the polymer matrix and can gradually release from the polymeric matrix into the eye (¶ [0007]). Hydrophobic comfort agents such as phospholipids including phosphatidylcholine can be added to strengthen and/or stabilize the tear film lipid layer (¶¶ [0059] – [0060]). The packaging solution can contain a viscosity-enhancing polymer such as HPMC to provide a film on the lens that may facilitate comfortable wearing of the contact lens (¶¶ [0100] – [0102]). DMPC is used in example 3 (beginning at ¶ [0136]) and as shown in example 4 (beginning at ¶ [0139]), the DMPC was released over time from the lens.
Iwasaki et al. discloses that the presence of DMPC liposomes on the MAPC (ω-methacryloyloxyalkyl phosphorylcholine) surface reduced fibrinogen, a protein, adsorption (abstract).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use liposomes such as SUVs comprised of DMPC as the phospholipid liposomal structure in the compositions of Sullivan et al., White et al. and Saavedra et al. that particularly in light of the teachings of Gram et al. would be expected to demonstrate reduced surface adsorption. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because DMPC is taught by Pruitt et al. and Iwasaki et al. as being suitable for use with soft contact lens to act as a comfort agent and also reduce surface adsorption such as the protein fibrinogen.
Applicants do not present any arguments regarding Pruitt et al. and Iwasaki et al. for the Examiner to address herein.
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, 4, 8, 11, 28, 52, 54, 57 and 58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 29 of copending Application No. 18/424,973 in view of Sullivan et al. (US 2014/0099343), White et al. (Biomaterials, 2011), Saavedra et al. (US 2006/0014013), Gram et al. (WO 2003/092382), Pruitt et al. (US 2010/0140114) and Iwasaki et al. (J Biomaterials Sci, 1999). The claims of US’973 recite a method for reducing a friction coefficient of a surface of a contact lens by rinsing and/or immersing the contact lens in a solution of at least one-water soluble polymer, liposomes comprised of phosphatidylcholine and an aqueous carrier with a particular liposome concentration (claim 1). The water soluble polymer can be hyaluronic acid (claim 5) which can form a hydrogel. Kits with the contact lens and solution of at least one-water soluble polymer, liposomes comprised of phosphatidylcholine and an aqueous carrier with a particular liposome concentration are also claimed (claim 9).
The presence of HPMC or DMPC is not claimed. That the liposomes can be SUVs is also not claimed.
Sullivan et al., White et al., Saavedra et al., Gram et al., Pruitt et al. and Iwasaki et al. are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to prepare compositions as in US’973 with HPMC and liposomes comprising phosphatidylcholine such as DMPC that can be small unilamellar vesicles that can be repeatedly applied to a contact lens. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because a contact lens is a surface that can be treated with such a composition as taught by the applied prior art and will provide various benefits to the contact lens such as when worn by a subject. The selection of the particular ingredients that fulfill functions in the composition from those that are known in the prior art is well within the skill of one of ordinary skill in the art. HPMC is disclosed by Sullivan et al. as part of a sacrificial mechanism on the contact lens and White et al. disclosed that 120kDa HPMC can form a layer on contact lens that in addition to the functions disclosed by Sullivan et al. can also alleviate contact lens induced dry eye. DMPC is taught by Pruitt et al. and Iwasaki et al. as being suitable for use with soft contact lens to act as a comfort agent and also reduce surface adsorption such as the protein fibrinogen. Such materials would reasonably be expected to demonstrate effects such as decreased surface adsorption of bacteria as taught by Gram et al. There is no persuasive evidence of unexpected results that demonstrate the criticality of the claimed functions.
Saavedra et al. discloses the coating of substrates using SUVs with a main phase transition temperature is equal to or greater than the temperature at which contact of the substrate is carried out. Features such as melting point (main phase transition temperature) of the liposomes and the change in surface adsorption on the contact lens substrate in the presence and absence of the claimed composition is determined by the composition itself. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 The main phase transition temperature can be altered by lipid selection and should be considered relative to the temperature at which substrate contacting and rinsing and/or immersing takes place so that the substrate can be coated with the lipids. There is currently no persuasive evidence of record that use of the compositions rendered obvious by the applied prior art do not have the features which are relied upon in the claims and/or that such materials are not rendered obvious by the teachings of the applied prior art and the knowledge of one of ordinary skill in the art.
While the preamble of the claims of US’973 and the instant claims are not the same, the active steps of US’973 and in view of the cited prior art results in the same active steps and the results must necessarily occur, whether that is described as a reduction of the friction coefficient of the surface or inhibiting biofilm formation as in the instant claims and the claims of US’111 and those of the instant application are not patentably distinguished.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 4, 8, 11, 28, 52, 54, 57 and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 5 and 8 - 11 of U.S. Patent No. 10,940,111 in view of Sullivan et al. (US 2014/0099343), White et al. (Biomaterials, 2011), Saavedra et al. (US 2006/0014013), Gram et al. (WO 2003/092382), Pruitt et al. (US 2010/0140114) and Iwasaki et al. (J Biomaterials Sci, 1999). The claims of US’11 recite a method of reducing a friction coefficient of a surface by contacting the surface with a solution comprising at least one water-soluble polymer (e.g., hyaluronic acid col 4, ln 50), liposomes and an aqueous carrier (claim 1), the carrier can be physiologically acceptable (claim 5).
The presence of HPMC or DMPC is not claimed. That the liposomes can be SUVs is also not claimed.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to prepare compositions as in US’111 with HPMC and liposomes comprising phosphatidylcholine such as DMPC that can be small unilamellar vesicles that can be repeatedly applied to a contact lens. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because a contact lens is a surface that can be treated with such a composition as taught by the applied prior art and will provide various benefits to the contact lens such as when worn by a subject. The selection of the particular ingredients that fulfill functions in the composition from those that are known in the prior art is well within the skill of one of ordinary skill in the art. HPMC is disclosed by Sullivan et al. as part of a sacrificial mechanism on the contact lens and White et al. disclosed that 120kDa HPMC can form a layer on contact lens that in addition to the functions disclosed by Sullivan et al. can also alleviate contact lens induced dry eye. DMPC is taught by Pruitt et al. and Iwasaki et al. as being suitable for use with soft contact lens to act as a comfort agent and also reduce surface adsorption such as the protein fibrinogen. Such materials would reasonably be expected to demonstrate effects such as decreased surface adsorption of bacteria as taught by Gram et al. There is no persuasive evidence of unexpected results that demonstrate the criticality of the claimed functions.
Saavedra et al. discloses the coating of substrates using SUVs with a main phase transition temperature is equal to or greater than the temperature at which contact of the substrate is carried out. Features such as melting point (main phase transition temperature) of the liposomes and the change in surface adsorption on the contact lens substrate in the presence and absence of the claimed composition is determined by the composition itself. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 The main phase transition temperature can be altered by lipid selection and should be considered relative to the temperature at which substrate contacting and rinsing and/or immersing takes place so that the substrate can be coated with the lipids. There is currently no persuasive evidence of record that use of the compositions rendered obvious by the applied prior art do not have the features which are relied upon in the claims and/or that such materials are not rendered obvious by the teachings of the applied prior art and the knowledge of one of ordinary skill in the art.
While the preamble of the claims of US’111 and the instant claims are not the same, the active steps of US’111 and in view of the cited prior art results in the same active steps and the results must necessarily occur, whether that is described as a reduction of the friction coefficient of the surface or inhibiting biofilm formation as in the instant claims and the claims of US’111 and those of the instant application are not patentably distinguished.
Claims 1, 4, 8, 11, 28, 52, 54, 57 and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 6 of U.S. Patent No. 11,633,358 in view of Sullivan et al. (US 2014/0099343), White et al. (Biomaterials, 2011), Saavedra et al. (US 2006/0014013) Gram et al. (WO 2003/092382), Pruitt et al. (US 2010/0140114) and Iwasaki et al. (J Biomaterials Sci, 1999). The claims of US’358 recite a method of reducing a friction coefficient of a surface by contacting the surface with a solution comprising at least one water-soluble polymer (e.g., hyaluronic acid claim 6), liposomes and an aqueous carrier (claim 1), the carrier of the composition can be physiologically acceptable (claim 7).
The presence of HPMC or DMPC is not claimed. That the liposomes can be SUVs is also not claimed.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to prepare compositions as in US’358 with HPMC and liposomes comprising phosphatidylcholine such as DMPC that can be small unilamellar vesicles that can be repeatedly applied to a contact lens. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because a contact lens is a surface that can be treated with such a composition as taught by the applied prior art and will provide various benefits to the contact lens such as when worn by a subject. The selection of the particular ingredients that fulfill functions in the composition from those that are known in the prior art is well within the skill of one of ordinary skill in the art. HPMC is disclosed by Sullivan et al. as part of a sacrificial mechanism on the contact lens and White et al. disclosed that 120kDa HPMC can form a layer on contact lens that in addition to the functions disclosed by Sullivan et al. can also alleviate contact lens induced dry eye. DMPC is taught by Pruitt et al. and Iwasaki et al. as being suitable for use with soft contact lens to act as a comfort agent and also reduce surface adsorption such as the protein fibrinogen. Such materials would reasonably be expected to demonstrate effects such as decreased surface adsorption of bacteria as taught by Gram et al. There is no persuasive evidence of unexpected results that demonstrate the criticality of the claimed functions.
Saavedra et al. discloses the