DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 19, 2025, has been entered.
Claims 10-15 are cancelled.
Claims 1-9 and 16-19 are pending. Claims 16-19 are withdrawn.
Claims 1-9 are examined on the merits.
Notice Re: Prior Art Available Under Pre-AIA and AIA
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.
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.
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, 3, 5, 6, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hecht (US 5,221,537. Previously cited) in view of Gelsomino (WO 2016/092513. Previously cited), and in light of Hatti-Kaul (FEMS Microbiology Letters. 2018. 365: fny213. 20 pages. Published August 30, 2018. Previously cited).
Hecht teaches an irrigating solution for use within the human body, particularly useful for irrigating tissues during surgery, such as ophthalmic surgery (column 1, lines 11-14). Example 2 of Hecht discloses a solution comprising water (meeting the claimed ‘water-based liquid carrier’), sodium phosphate dibasic (which is synonymous with disodium phosphate), magnesium chloride hexahydrate, and calcium chloride dihydrate, which was adjusted to a pH of 6.8-8.0 (column 7, lines 20-39). The pH of 6.8-8.0 overlaps with the claimed pH range of ‘from 6.7 to 6.9,’ thus rendering obvious the claimed pH. Therefore, the solution of Hecht comprises a buffer system comprising disodium phosphate in an amount to yield a pH that falls within the claimed range of ‘from 6.7 to 6.9.’ The solution of Example 2 of Hecht further can comprise l-sodium lactate (column 7, line 32). Hecht teaches l-lactic acid as an alternative to its disodium salt (column 5, lines 55-56). Given that teaching, it would have been obvious to substitute the 1-sodium lactate of Example 2 with l-lactic acid. Therefore, Hecht renders obvious the solution of Example 2 comprising l-lactic acid.
L-lactic acid is known in the art as a fermented product of Lactobacillus paracasei, thereby being directed to the ‘postbiotic’ as recited in instant claim 1 and defined in the specification as “a fermented or fermentation product of the species Lactobacillus casei or Lactobacillus paracasei or mixtures thereof” (page 6, lines 3-6). For instance, see page 3, left column, last paragraph and right column, last paragraph of Hatti-Kaul. Since Hecht renders obvious a solution suitable for irrigating tissues during ophthalmic surgery comprising l-lactic acid, water, sodium phosphate dibasic (i.e. disodium phosphate), magnesium chloride hexahydrate, calcium chloride dihydrate, and a pH overlapping the claimed range of from 6.7 to 6.9, then Hecht renders obvious a composition comprising the claimed ‘postbiotic,’ a water-based liquid carrier, a buffer system comprising disodium phosphate in an amount to yield the claimed pH, and an isotonising agent comprising magnesium chloride hexahydrate and calcium dihydrate, meeting limitations of the claimed invention.
Hecht (in light of Hatti-Kaul, cited as evidence) differs from the claimed invention in that Hecht does not expressly disclose:
The solution comprises sodium phosphate monohydrate and disodium phosphate dodecahydrate in amounts to yield a pH from 6.7 to 6.9; and
The solution is a ‘stable eye topical composition’ wherein ‘stable’ is defined in the
instant specification as “the composition has a mean particle dispersion (size) ≤ 200 nm, in particular with reference to the postbiotic, at 40ºC and 25ºC at six months” (page 5, lines 15-17).
Regarding difference (1) (Hecht does not disclose that their solution comprises sodium phosphate monohydrate and disodium phosphate dodecahydrate in amounts to yield a pH from 6.7 to 6.9):
Gelsomino discloses an ophthalmic pharmaceutical composition for use in the treatment of the dry eye syndrome (abstract). The ophthalmic pharmaceutical composition has a pH comprised between 5.5 and 7.5 (page 8, lines 7-8), and can further contain at least one component selected from a group comprising buffering agents, osmolarity regulators, and mixtures thereof (page 8, lines 15-17). Examples of buffering agents include sodium phosphate and mixtures of the buffering agents (page 8, lines 22-26). In Example 1, an eye drop formulation is prepared by mixing hydrocortisone sodium phosphate and sodium hyaluronate with other conventional ingredients according to a method known to a person skilled in the art (page 9, line 25 through page 10, line 1). The conventional ingredients include magnesium chloride hexahydrate, Na2HPO4 dodecahydrate (i.e. disodium phosphate dodecahydrate), and Na2HPO4 monohydrate (i.e. sodium hydrogen phosphate monohydrate) (Table 1 on page 10). Purified water is also included to balance to 100 mL (Table 1 on page 10).
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to substitute the sodium phosphate dibasic of the solution rendered obvious by Hecht (in light of Hatti-Kaul, cited as evidence) with Na2HPO4 dodecahydrate and Na2HPO4 monohydrate. It would have been a matter of simple substitution of a sodium phosphate with a combination of sodium phosphates. Also, the substitution would have been obvious since Gelsomino teaches the combination of Na2HPO4 dodecahydrate and Na2HPO4 monohydrate in an ophthalmic composition. There would have been a reasonable expectation of obtaining a solution suitable for irrigating tissues during ophthalmic surgery as sought by Hecht since Na2HPO4 dodecahydrate and Na2HPO4 monohydrate are taught in Gelsomino as suitable for inclusion in an ophthalmic composition. In making the substitution with agents recognized in Gelsomino as buffering agents, then it would have been obvious to adjust their amounts to yield the pH desired by Hecht of 6.8-8.0 (column 7, lines 20-39). There would have been a reasonable expectation of adjusting their amounts to the pH desired by Hecht because the sodium phosphates are recognized in Gelsomino as buffering agents for inclusion in an ophthalmic pharmaceutical composition having a pH comprised between 5.5 and 7.5 (page 8, lines 7-26). As stated above, the pH of 6.8-8.0 overlaps with the claimed range of ‘from 6.7 to 6.9,’ thus rendering obvious the claimed pH.
Regarding difference (2) (Hecht does not disclose that their solution is a ‘stable eye topical composition’ according to the definition of the term ‘stable’ on page 5, lines 15-17 of the instant specification):
The term ‘stable’ is defined in the instant specification as “the composition has a mean particle dispersion (size) ≤ 200 nm, in particular with reference to the postbiotic, at 40ºC and 25ºC at six months” (page 5, lines 15-17). This is directed to a property of the claimed composition. Moreover, the term ‘eye topical’ in instant claim 1 sets forth the intended use of the claimed composition. According to MPEP 2112(I), “‘[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.’” Moreover, MPEP 2112(I) also states, “Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.” Since Hecht in view of Gelsomino (in light of Hatti-Kaul) renders obvious a composition comprising the same components, including the claimed ‘postbiotic,’ then the composition rendered obvious by the references is necessarily ‘stable’ as defined in the instant specification. Further still, since the solution is suitable for irrigating tissues during ophthalmic surgery (as taught in Hecht), then the solution rendered obvious by Hecht in view of Gelsomino (in light of Hatti-Kaul) is safe for the claimed intended use of topical administration to eyes. Since the composition rendered obvious by the references is in the form of a solution, then it is in a form suitable for the claimed intended use of topical administration to eyes. Therefore, the solution rendered obvious by the references is also directed to an ‘eye topical composition.’
As such, Hecht in view of Gelsomino (in light of Hatti-Kaul, cited as evidence) renders obvious instant claims 1 and 3 (sodium chloride, potassium chloride, and mixture thereof; see Example 2 of Hecht at column 7, lines 20-39).
Regarding instant claim 5, Hecht in view of Gelsomino (in light of Hatti-Kaul) differs from the claimed invention in that Hecht does not expressly disclose that their solution further comprises a glycerol based suspending-isotonising agent. As pointed out above, Gelsomino teaches an ophthalmic pharmaceutical composition which can further contain mixtures of buffering agents and osmolarity regulators (page 8, lines 15-17). Examples of the osmolarity regulators include potassium chloride, sodium chloride, and glycerin (i.e. glycerol), and mixtures of the osmolarity regulators (page 8, line 27 through page 9, line 2). Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to include glycerin (i.e. glycerol) in the solution rendered obvious by Hecht in view of Gelsomino (in light of Hatti-Kaul, cited as evidence). One of ordinary skill in the art would have been motivated to do this because, as taught in Gelsomino, glycerin is an osmolarity regulator for inclusion in an ophthalmic pharmaceutical composition which can be provided with other osmolarity regulators such as potassium chloride and sodium chloride which are in the solution of Hecht (column 7, lines 20-39) directed to an ophthalmic composition. Osmolarity regulation would have been desired for the solution rendered obvious by Hecht and Gelsomino (in light of Hatti-Kaul) because Hecht teaches that in order to maintain the osmotic stability of the cells of the tissues to be irrigated, the osmolality of the solution should be in a specific range (column 5, line 68 through column 6, line 4). Glycerin (i.e. glycerol) meets the claimed limitation of a ‘glycerol based suspending-isotonising agent.’ Thus, instant claim 5 is rendered obvious.
Regarding instant claim 6, Hecht in view of Gelsomino (in light of Hatti-Kaul) differs from the claimed invention in that Hecht does not expressly disclose that their solution comprises a further buffer which is sodium citrate. As pointed out above, Gelsomino teaches an ophthalmic pharmaceutical composition which can further contain mixtures of buffering agents and osmolarity regulators (page 8, lines 15-17). Examples of buffering agents include sodium phosphate and sodium citrate, and mixtures of the buffering agents (page 8, lines 22-26). In Example 1, the eye drop formulation includes conventional ingredients that include trisodium citrate dihydrate (directed to sodium citrate) as well as magnesium chloride hexahydrate, Na2HPO4 dodecahydrate (i.e. disodium phosphate dodecahydrate), and Na2HPO4 monohydrate (i.e. sodium hydrogen phosphate monohydrate) (Table 1 on page 10). Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to include sodium citrate in the solution rendered obvious by Hecht in view of Gelsomino (in light of Hatti-Kaul, cited as evidence). One of ordinary skill in the art would have been motivated to do this because, as taught in Gelsomino, sodium citrate is a buffering agent for inclusion in an ophthalmic pharmaceutical composition which can be provided with other buffering agents such as sodium phosphates which are in the solution rendered obvious by Hecht and Gelsomino (in light of Hatti-Kaul, cited as evidence) directed to an ophthalmic composition. Thus instant claim 6 is rendered obvious.
Regarding instant claim 8, Example 2 of Hecht discloses the magnesium chloride hexahydrate in an amount of 0.16-0.24 mg/mL and the calcium chloride dihydrate in an amount of 0.12-0.18 mg/mL (column 7, lines 25-27). Thus, any combination of these amounts is rendered obvious by Hecht. The ratio of the highest amount of magnesium chloride hexahydrate (0.24 mg/mL) to the lowest amount of calcium chloride dihydrate (0.12 mg/mL) is 2, and the ratio of the highest amount of magnesium chloride hexahydrate to the highest amount of calcium chloride dihydrate (0.18 mg/mL) is 1.3. Therefore, Hecht at least renders obvious a weight ratio range of magnesium chloride hexahydrate to calcium chloride dihydrate of 1.3 to 2, which includes the claimed weight ratio of 1.42. As such, instant claim 8 is rendered obvious by Hecht in view of Gelsomino (in light of Hatti-Kaul).
Regarding instant claim 9, Hecht in view of Gelsomino (in light of Hatti-Kaul) differs from the claimed invention in Hecht does not expressly disclose a composition having a particle average dispersion size ≤ 200 nm at 40ºC after six months (Note: the claimed limitation ‘after six months’ is different from the disclosure of “at six months” for the definition of the limitation ‘stable’ in the instant specification on page 5, lines 15-17). According to MPEP 2112(I), “’[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.’” Moreover, MPEP 2112(I) also states, “Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.” Since Hecht in view of Gelsomino (in light of Hatti-Kaul) renders obvious an eye topical composition comprising the same components, including the claimed ‘postbiotic,’ then it necessarily possesses the claimed characteristic of having a particle average dispersion size ≤ 200 nm at 40ºC after six months. Therefore, instant claim 9 is rendered obvious.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hecht, Gelsomino, and Hatti-Kaul as applied to claims 1, 3, 5, 6, 8, and 9 above, and further in view of Rescigno (WO 2018/024833. Listed on IDS filed 6/3/22).
As discussed above, Hecht in view of Gelsomino (in light of Hatti-Kaul, cited as evidence) renders obvious claims 1, 3, 5, 6, 8, and 9. The references differ from claim 2 in that Hecht does not expressly disclose that the l-lactic acid (directed to the claimed ‘postbiotic’) is a fermented product of the Lactobacillus paracasei strain CNCM I-5220.
As pointed out above, l-lactic acid is known in the art as a fermented product of Lactobacillus paracasei. For instance, see page 3, left column, last paragraph and right column, last paragraph of Hatti-Kaul.
Rescigno discloses Lactobacillus paracasei strain CNCM I-1390 which had been redeposited with CNCM no. I-5220 (page 4, lines 9-12).
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to substitute the l-lactic acid with l-lactic acid produced by Lactobacillus paracasei strain CNCM I-5220 in the composition rendered obvious by Hecht in view of Gelsomino (in light of Hatti-Kaul, cited as evidence). It would have been a matter of simple substitution of one l-lactic acid for another for the predictable result of obtaining the composition rendered obvious by Hecht and Gelsomino (in light of Hatti-Kaul). There would have been a reasonable expectation that l-lactic acid is produced by L. paracasei strain CNCM I-5220 because l-lactic acid is known in the art as a fermented product of L. paracasei, as evidenced by Hatti-Kaul. Thus instant claim 2 is rendered obvious.
Claims 2, 4, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Hecht, Gelsomino, and Hatti-Kaul as applied to claims 1, 3, 5, 6, 8, and 9 above, and further in view of Rescigno (WO 2018/024833. Listed on IDS filed 6/3/22) and Naserke (WO 2011/138228. Previously cited).
As discussed above, Hecht in view of Gelsomino (in light of Hatti-Kaul, cited as evidence) renders obvious claims 1, 3, 5, 6, 8, and 9. Regarding instant claim 4, Hecht teaches in Example 2 that the solution comprises l-sodium lactate in an amount of 1.00-1.25 mg/mL. See the ingredients of the solution of Example 2 in column 7, lines 25-40. This converts to 0.100-0.125% (w/v) l-sodium lactate [Calculation example:
1.00
m
g
m
L
×
g
1000
m
g
×
100
=
0.100
%
(
w
v
)
]. In the composition rendered obvious by Hecht and Gelsomino (in light of Hatti-Kaul) in which the l-sodium lactate is substituted with 1-lactic acid, then the references render obvious the postbiotic (l-lactic acid) at a concentration of 0.1-0.125% (w/v) which falls within the range for the postbiotic of instant claim 4. Also, the water for injection is QS (known in the art as the amount which is enough) to final volume. Hecht in view of Gelsomino (in light of Hatti-Kaul) differs from instant claim 4 in that the references do not expressly disclose that the l-lactic acid (directed to the claimed ‘postbiotic’) is from Lactobacillus paracasei CNCM no. I-5220, the sodium hydrogen phosphate monohydrate is in an amount of 0.0350-0.1600% (w/v), the disodium phosphate dodecahydrate is in an amount of 0.0890-0.4100% (w/v), the magnesium chloride hexahydrate is in an amount of 0.0060-0.0120% (w/v), the calcium chloride dihydrate is in an amount of 0.0042-0.0084% (w/v), and the water for injection is purified water in which the QS to final volume is to a final volume of 100 mL.
Regarding instant claim 7, Hecht in view of Gelsomino (in light of Hatti-Kaul) renders obvious a solution comprising l-lactic acid (directed to a ‘postbiotic’), sodium hydrogen phosphate monohydrate, disodium phosphate dodecahydrate, sodium citrate, sodium chloride, potassium chloride, magnesium chloride hexahydrate, calcium chloride dihydrate, glycerol, and water for injection at QS to final volume. See the ingredients of the solution of Example 2 in column 7, lines 25-40 of Hecht and the rejection of claims 5 and 6 above. The references differ from instant claim 7 in that they do not expressly disclose that the l-lactic acid (directed to the claimed ‘postbiotic’) is from Lactobacillus paracasei CNCM no. I-5220 and is in an amount of 0.28% (w/v), the sodium hydrogen phosphate monohydrate is in an amount of 0.1600% (w/v), the disodium phosphate dodecahydrate is in an amount of 0.4100% (w/v), the sodium citrate is in an amount of 0.0590% (w/v), the sodium chloride is in an amount of 0.3500% (w/v), the potassium chloride is in an amount of 0.1500% (w/v), the magnesium chloride hexahydrate is in an amount of 0.0120% (w/v), the calcium chloride dihydrate is in an amount of 0.0084% (w/v), the glycerol is in an amount of 0.5000% (w/v), and the water is purified water at QS to 100 mL.
As pointed out above, l-lactic acid is known in the art as a fermented product of Lactobacillus paracasei. For instance, see page 3, left column, last paragraph and right column, last paragraph of Hatti-Kaul.
Rescigno discloses Lactobacillus paracasei strain CNCM I-1390 which had been redeposited with CNCM no. I-5220 (page 4, lines 9-12).
In Example 1 of Gelsomino discussed above, the eye drop formulation comprises conventional ingredients (buffering agents and osmolarity regulators) which are sodium chloride, potassium chloride, trisodium citrate dihydrate (directed to sodium citrate), magnesium chloride hexahydrate, Na2HPO4 dodecahydrate (i.e. disodium phosphate dodecahydrate), and Na2HPO4 monohydrate (i.e. sodium hydrogen phosphate monohydrate) (Table 1 on page 10). Purified water is also included to balance to 100 mL (Table 1 on page 10). The quantities of these components convert to the following amounts: 0.008% (w/v) sodium hydrogen phosphate monohydrate, 0.053% (w/v) disodium phosphate dodecahydrate, 0.038% (w/v) trisodium citrate dihydrate (directed to sodium citrate), 0.745% (w/v) sodium chloride, 0.180% (w/v) potassium chloride, and 0.0130% (w/v) magnesium chloride hexahydrate [Calculation example:
8
m
g
100
m
L
×
g
1000
m
g
×
100
=
0.008
%
(
w
/
v
)
].
Naserke discloses an aqueous composition that addresses the long-felt need for an artificial tear composition that has excellent lubrication properties, reduces fluid evaporation to maintain the tear film, regulates the homeostasis of water and ions, has a sufficient surface tension that allow extension over the epithelial surface, provides a surface preventing adhesion of the ocular surface to a contact lens or eye lid and/or provides a biological barrier to pathogens such as bacteria or viruses (paragraphs [0014]-[0017]). The osmolarity of the composition can be controlled by a tonicity adjusting agent such as glycerol (paragraph [0048]). The composition may further comprise ions or salts, wherein in some embodiment of the invention, the salts are selected from sodium chloride, potassium chloride, disodium phosphate, sodium citrate, magnesium chloride, and calcium chloride or mixtures thereof (paragraph [0050]). The concentrations of the potassium, magnesium and/or calcium ions are about 0.001 to about 0.1% by weight of the formulation (paragraph [0051]). In one embodiment, the composition may comprise sodium chloride, for example in a concentration of about 0.01 to about 2% by weight (paragraph [0055]). In some embodiments, the composition comprises one or more alcohols selected from a group that includes glycerol (paragraph [0058]). The invented compositions of Naserke may have a pH in the range of from about 6 to about 8 (paragraph [0063]). Finally, Naserke teaches an embodiment of their invention comprising about 0.28% by weight sodium chloride, about 0.1% by weight potassium chloride, about 0.32% by weight disodium phosphate dodecahydrate, about 0.026% by weight sodium citrate, about 0.01% by weight magnesium chloride hexahydrate, about 0.01% by weight calcium chloride dihydrate, and about 5% by weight glycerol (paragraph [0065]).
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to substitute the l-lactic acid with l-lactic acid produced by Lactobacillus paracasei strain CNCM no. I-5220 in the composition rendered obvious by Hecht in view of Gelsomino (in light of Hatti-Kaul, cited as evidence). It would have been a matter of simple substitution of one l-lactic acid for another for the predictable result of obtaining the composition rendered obvious by Hecht and Gelsomino (in light of Hatti-Kaul). There would have been a reasonable expectation that l-lactic acid is produced by L. paracasei strain CNCM no. I-5220 because l-lactic acid is known in the art as a fermented product of L. paracasei, as evidenced by Hatti-Kaul.
In making that substitution, then instant claim 2 is rendered obvious.
Further still, before the effective filing date of the claimed invention, in the solution rendered obvious by Hecht in view of Gelsomino (in light of Hatti-Kaul) in further view of Rescigno, it would have been an obvious matter of routine optimization to vary the concentrations of the components of the solution to the concentrations recited in instant claims 4 and 7 since the skilled artisan would have recognized that the concentrations of the components can be varied to yield desired levels of buffering and osmolarity regulation. Though the concentrations of the components as taught in Hecht, Gelsomino, and Naserke are different from the claimed concentrations, the concentrations taught in the prior art would have served as starting points for varying the concentrations. It is noted that “[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). Moreover, it would have been obvious to substitute the water with purified water and to add the purified water to obtain a final volume of 100 mL (i.e. q.s. to 100 mL) since Gelsomino teaches doing so for an ophthalmic composition.
Therefore, Hecht in view of Gelsomino (in light of Hatti-Kaul) and further in view of Rescigno and Naserke renders obvious instant claims 4 and 7.
Response to Arguments
Applicant’s arguments, filed November 19, 2025, with respect to the rejection under 35 U.S.C. 112(b) of claim 2, have been fully considered and are persuasive. In particular, the rejection under 35 U.S.C. 112(b) has been overcome by the amendment to claim 2. Thus, this rejection has been withdrawn.
However, Applicant’s arguments are unpersuasive with respect to the rejections under 35 U.S.C. 103 over the previously cited prior art, wherein the ground of rejection has been modified. The rejection under 35 U.S.C. 103 of claim 2 has been modified as necessitated by the amendment to claim 2.
With respect to claim 1 being directed to a “stable eye topical composition,” Applicant asserts that page 2, lines 24-26 of the present application is part of the definition of the rejected claims. However, this passage of the specification does not include language that makes it clear that the term “stable eye topical composition” has the special definition of being a composition possessing an ability to act at eye surface level, having high efficacy and wide safety margin (note that even if this were included in a definition, “high efficacy” and “wide safety margin” would be considered indefinite terms), and possessing the ability to prevent or cure diseases in the ocular segment. Therefore the Examiner maintains the following: In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., acting on eye surface level thereby enabling to be performed, with high efficacy and a wide safety margin) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
As set forth in MPEP 2111.01((I), “Under a broadest reasonable interpretation (BRI), words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the relevant time.” The plain meaning has been applied to a “stable eye topical composition” in the examination of the claims while incorporating the special definition of the term “stable” provided in the specification at page 5, lines 15-17 (“In the present document, the term ‘stable’ means that…”). Though the Applicant may be their own lexicographer, as set forth in MPEP 2111.01(IV), “To act as their own lexicographer, the applicant must clearly set forth a special definition of a claim term in the specification that differs from the plain and ordinary meaning it would otherwise possess.” In this case, Applicant has not set forth a special definition of “stable eye topical composition” as being limited to a composition having the properties on page 2, lines 24-26 of the specification.
Applicant also cites page 8, lines 5-6 of the application regarding the safety profile of the formulation evaluated on the human corneal epithelial cell line. Applicant asserts that the epithelium, by definition, is a surface tissue, so the corneal epithelium is the surface of the eye and can therefore be treated topically. On the contrary, the endothelium, by definition, is an internal tissue and thus is not a surface tissue of the eye and cannot therefore be treated topically. Therefore, Applicant argues that Hecht cannot be construed to be directed to a stable eye topical composition, and the relied-upon limitation is present in the language of pending claim 1. As such, Applicant asserts that Hecht cannot be construed as being directed to a stable eye topical composition. It appears Applicant is referring to teachings in Hecht that their ophthalmic irrigating solutions protect the endothelium during ophthalmic surgery, and the irrigation of corneal endothelial tissue during ophthalmic surgery with their irrigating solution (e.g., column 4, lines 28-32; claim 1 of Hecht). In view of these arguments, the Examiner agrees that Hecht does not explicitly disclose the topical administration of their irrigating solution to an eye. Therefore, the ground of rejection has been modified, recognizing that “eye topical” in the recitation “stable eye topical composition” is directed to the intended use of the claimed composition, and the term “stable” (according to the definition on page 5, lines 15-17 of the specification) is a property of the claimed composition.
Additionally, Applicant rebuts the Examiner’s arguments regarding the term “postbiotic.” Applicant argues that the Examiner disregarded the paragraph after the definition of “postbiotic” on page 6, lines 3-6 of the specification. Specifically, Applicant cites page 6, lines 7-12 of the application which refers to a “mixture of biosurfactants, glycoproteins and organic acids and peptides present in the postbiotic.” Applicant asserts that it is not a reasonable interpretation to read in the definition (page 6, lines 3-6) the possibility that a single compound can achieve the result described as achieved by a mixture being complex in nature. However, the instant claims do not require that the composition has a barrier effect on the epithelial cells. Since the cited passage (page 6, lines 7-12) states, “when the composition according to any one of the previous embodiments has a barrier effect on the epithelial cells,” then the cited passage describing the mixture of biosurfactants, etc., applies only when the composition has that barrier effect. Therefore, the definition of the term “postbiotic” is not limited to a fermented product comprising a mixture of biosurfactants, glycoproteins, organic acids, and peptides as recited in the cited passage. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the composition has a barrier effect on the epithelial cells; the postbiotic comprises a mixture of biosurfactants, glycoproteins, organic acids, and peptides) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Additionally, Applicant cites Nataraj (reference listed on the IDS filed 11/19/25. Published August 20, 2020) for providing a definition of postbiotics as being a complex mixture of metabolic products secreted by probiotics in cell-free supernatants, and discussion regarding the definition of postbiotics. Applicant also presents arguments with respect to Figure 1 of Rescigno. However, Applicant has provided an explicit definition of the term “postbiotic” by stating on page 6, lines 3-6 of the specification, “Within the scope of the present invention, the term postbiotic means a fermented or fermentation product of the species Lactobacillus casei or Lactobacillus paracasei or mixtures thereof.” As indicated in MPEP 2111.01(IV)(A), “Where an explicit definition is provided by the applicant for a term, that definition will control interpretation of the term as it is used in the claim.” Since a special definition of the claim term “postbiotic” has been provided by the Applicant on page 6, lines 3-6 of the application, then that definition controls the interpretation of the term, as opposed to the definition provided in Nataraj or in Figure 1 of Rescigno.
Additionally, Applicant argues that Rescigno teaches sodium lactate as a fermentation substrate (page 5, lines 8-9 and page 6, line 5) so sodium lactate (or lactic acid) cannot be regarded as both a fermentation substrate and product. However, the fact that sodium lactate is used as a fermentation substrate in the method of Rescigno does not signify that lactic acid/lactate is not a fermentation product of the CNCM I-5220 strain of Rescigno. In a fermentation process, fermentation products can be formed that can undergo further reaction to convert to other products (a product can be a substrate for a subsequent reaction to form another product).
Conclusion
No claims are allowed.
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/SUSAN E. FERNANDEZ/ Examiner, Art Unit 1651