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 .
Response to Amendment
2. Applicant’s amendment and response, submitted November 3, 2025, has been reviewed by the examiner and entered of record in the file.
3. Claims 39 and 40 are amended. No claim is cancelled or added.
4. Claims 39-47 are under examination and are the subject of this office action.
Previous Claim Rejections - 35 USC § 112
5. Claims 39-47 were previously rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
6. Claim 39 was rejected as being indefinite regarding the recitation in step b) following the term “borate,” i.e., “wherein the term “borate” means boric acid, salts of boric acid and other pharmaceutically acceptable borates, or combinations thereof”. In view of Applicant’s amendment to delete the recitation “wherein the term “borate” means” and replace with “selected from,” the previous indefiniteness rejection is withdrawn.
7. The rejection of claims 40-47 as being dependent upon and including all of the limitations of claim 39 is also withdrawn.
Previous Claim Rejections - 35 USC § 112(a)
8. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
9. Claims 39-47 remain 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 claims contain 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
10. In particular, support cannot be found for a composition comprising the repeating polymer polyquaternium-42 at any weight of from 250 to 12,000 Daltons; a polyol or combination of polyols selected from polysorbate 80, mannitol, sorbitol, propylene glycol, polyethylene glycol, or glycerin; a borate, boric acid, salt of boric acid, or a combination thereof; an antimicrobial mixture comprising: a lactate selected from sodium lactate, potassium lactate, and mixtures thereof; a citrate selected from citric acid, sodium citrate, potassium citrate and mixtures thereof; a phosphate selected from sodium phosphate, disodium phosphate, potassium phosphate and mixtures thereof; and glucose, and optionally an electrolyte mixture comprising a potassium salt selected from potassium chloride, potassium phosphate, and mixtures thereof; sodium chloride; and magnesium chloride, as instantly claimed.
11. The MPEP §2163 states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. In the case of chemical entities, Applicant's attention is further directed to Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), which notes that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, “not a mere wish or plan for obtaining the claimed chemical invention.” While the court recognizes that, “[i]n claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass” (Id.), it is also recognized that for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim and/or the genus must be sufficiently detailed to show that applicant was in possession of the claimed invention as a whole (see Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991)). If a genus has substantial variance, the disclosure must present a sufficient number of representative species that encompass the genus in order to adequately describe the genus (i.e., the disclosure must describe a sufficient variety of species to reflect the variation within that genus). See MPEP § 2163. Otherwise, as stated by the court in Ariad Pharmaceuticals, Inc., v. Eli Lilly and Company (Fed. Cir. 2010), “a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus.
12. In the instant case, it is evident that the breadth of compositions comprising any/all combination(s) of the following components: (a) polyquaternium-42 at any weight of from 250 to 12,000 Daltons; (b) a borate, boric acid, salt of boric acid, or a combination thereof; (c) a polyol or combination of polyols selected from polysorbate 80, mannitol, sorbitol, propylene glycol, polyethylene glycol, or glycerin; and (d) an antimicrobial mixture comprising: (i) a lactate selected from sodium lactate, potassium lactate, and mixtures thereof; (ii) a citrate selected from citric acid, sodium citrate, potassium citrate and mixtures thereof; (iii) a phosphate selected from sodium phosphate, disodium phosphate, potassium phosphate and mixtures thereof; and (iv) glucose, and optionally an electrolyte mixture comprising a potassium salt selected from potassium chloride, potassium phosphate, and mixtures thereof; sodium chloride; and magnesium chloride, has substantial variance.
The variations of possible combinations of (a)-(d) and (i)-(iv) are virtually without limit, embracing hundreds of millions of potential compositions and alternatives, however the instant Specification has not demonstrated support for such breadth. The instant Specification discloses the preparation of only approximately 20 compositions (1A-1D), 2A-2B, 4A-4C, 5A-5C, 6A-6E, and 7A-7C), wherein on about 13 of said compositions demonstrate preservative efficacy within Table 8, i.e., the compositions of Examples 1A-1D, 2A-2B, 6A-6D, and 7A-7C.
13. Thus, it is recommended that the scope of the composition be limited to that which is described in the Specification, i.e., limit the claims to the compositions of Examples 1A-1D, 2A-2B, 6A-6D, and 7A-7C as disclosed in Table 8.
Response to Arguments
14. Applicant argues that the amendments to claim 39, which limit the borate to a; the polyol to polysorbate 80, mannitol, sorbitol, propylene glycol, polyethylene glycol, glycerin or mixtures thereof; limit the lactate to sodium lactate, potassium lactate, and mixtures thereof; limit the citrate to citric acid, sodium citrate, potassium citrate, and mixtures thereof; limit the phosphate to sodium phosphate, disodium phosphate, potassium phosphate and mixtures thereof; and limit “a glucose” to “glucose,” should obviate the previous rejection under 35 U.S.C. 112(a) rejection.
15. Applicant's arguments have been fully considered but they are not persuasive. While the amendments to claims 39 and 40 slightly limit the subgenus of each of components (a)-(d) and (i)-(iv) in claim 39, as well as the electrolyte components (i)-(iii) in claim 40, the claims still embrace hundreds of thousands, if not millions, of compositions comprising all possible combinations of ingredients (a)-(d) and (i)-(iv). Applicant has not demonstrated that they have possession of the full scope of all of the possible combinations of (a)-(d) and (i)-(iv) and alternative combinations thereof. In the Specification at pages 18-57, Applicant demonstrates the preparation of only 18 compositions comprising various combinations of components (a)-(d) and (i)-(iv) in Examples 1A-1D, 2A-2B, 3A-3E, 6A-6D, and 7A-7C. Thus it is suggested that the claims be limited to those compositions which have support in the Specification, i.e., limit the claims to the compositions of Examples 1A-1D, 2A-2B, 6A-6D, and 7A-7C as disclosed in Table 8.
16. Applicants have failed to provide guidance or data or evidence as to how the skilled artisan would be able to extrapolate from the disclosure to make the claimed invention. That is, the specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116). The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521,222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.").
17. Accordingly, it is deemed that the specification fails to provide adequate written description for the claimed invention and does not reasonably convey to one skilled in the relevant art that the inventors had possession of the entire scope of the claimed invention.
Previous Claim Rejections - 35 USC § 103
18. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
19. Claims 39-44, 46 and 47 remain rejected under 35 U.S.C. 103 as being unpatentable over Coffey et al., U.S. 2011/0319502 A1, further in view of Beard et al., CA 2898217 A1.
Claim 39, as amended, is drawn to a composition comprising:
a) 0.0010% w/v to about 0.0050 % w/v polyquaternium-42;
b) 0.06% w/v to about 1.0% w/v a borate selected from boric acid, salts of boric acid, and other pharmaceutically acceptable borates;
c) 0.4% w/v to about 1.5 % w/v of a polyol selected from polysorbate 80, mannitol, sorbitol, propylene glycol, polyethylene glycol, glycerin or mixtures thereof (more specifically, polysorbate 80 and/or glycerin (claim 47)); and
d) an antimicrobial mixture, wherein the total nutrient concentration in the composition of the present invention comprises:
i. a lactate selected from sodium lactate, potassium lactate, and mixtures thereof, providing a lactate concentration of from 2.0 mMol/L to 3.0 mMol/L of the total composition,
ii. a citrate selected from citric acid, sodium citrate, potassium citrate and mixtures thereof, providing a citrate concentration of from 0.025 mMol/L to 0.050 mMol/L of the total composition,
iii. a phosphate selected from sodium phosphate, disodium phosphate, potassium phosphate and mixtures thereof, providing a phosphate concentration of from 1.5 mMol/L to 2.5 mMol/L of the total composition, and
iv. glucose at a concentration of from 0.1 mMol/L to 0.4 mMol/L of the total composition,
(more specifically lactate and citrate and phosphate), and
wherein the composition is free of, or substantially free of zinc ions (claim 46).
20. Coffey et al. teach ophthalmic compositions, e.g., for treating or controlling dry eye and/or inflammation (see Examples 21-23, page 15), having enhanced preservative efficacy, that are free of the ammonium-containing preservative benzalkonium chloride (BAK), known to cause eye irritation (page 1, paragraph [0006]), and suggest alternative ammonium-containing compounds as preservatives, in particular naming polyquaternium-1 and polyquaternium-42 (pages 2-3, paragraph [0032]). Coffey et al. teach a preferred ophthalmic composition in Table 2, comprising 1-30 ppm polyquaternium-1, (b) 0.05-2% boric acid, (c) a polyol, polysorbate 80 (0.1-5%) and/or glycerin (0-3%), and (d) iii. a phosphate, 0.142% sodium phosphate dibasic anhydrous; and (d) iv. a glucose, 0.1-3% D-glucose:
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21. The composition disclosed in Table 2 of Coffey et al. does not comprise zinc ions, which meets the limitation of claim 46.
22. Nothing unobvious is seen in one of skill in the art substituting the preservative polyquaternium-42 for the polyquaternium-1 in the composition of Table 2, particularly because they are both named as alternatives for benzalkonium chloride by Coffey et al. in paragraph [0032]. And, as noted by the court in In re Font, 675 F.2d 297 (CCPA 1982), an express suggestion to substitute one equivalent component (i.e., an equivalent polyquaternium preservative) for another is not necessary to render such substitution obvious. In the instant case, (1) the prior art element of Coffey et al. performs the function specified in the claim with only insubstantial differences; (2) the claimed component (i.e., polyquaternium-42) and its function was known in the art; (3) a person of ordinary skill in the art would have recognized the interchangeability of the elements and could have substituted one known element for another; and (4) the results of the substitution would have been predictable, i.e., enhanced preservative efficacy of ophthalmic compositions.
23. As such, Coffey et al. teach an ophthalmic composition comprising components (a), (b), (c) and (d)iii and iv, but are silent to (d)i lactate and (d)ii citrate compounds in the “antimicrobial mixture” of component (d).
24. Yet, Beard et al. teach an ophthalmic composition in the form of an eye drop for treating dry eye syndrome (page 2, last two paragraphs), comprising at least one buffering agent selected from about 0.1% sodium citrate dehydrate, and about 0.3% sodium lactate (page 4, last paragraph- page 5, first paragraph). Beard et al. refer to sodium citrate and sodium lactate as buffering agents, while instant claim 30 labels lactate and citrate as components in an antimicrobial mixture. However, the fact that Applicant has recognized another advantage (i.e., employing sodium citrate and sodium lactate as “antimicrobials”), which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
25. Regarding the recited concentration(s) of lactate (2.0-3.0 mMol/L), citrate (0.025 mMol/L to 0.050 mMol/L), phosphate (1.5 mMol/L to 2.5 mMol/L) and glucose (0.1 mMol/L to 0.4 mMol/L), it would have been obvious for one of ordinary skill in the art to use the starting point of 0.142% sodium phosphate dibasic anhydrous, 0.1-3% glucose, about 0.1% sodium citrate dehydrate, and about 0.3% sodium lactate, disclosed by Coffey et al. and Beard et al., and optimize these amounts in a composition for intraperitoneal administration, with a reasonable expectation of success. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also 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 optimization with a reasonable expectation of success.
26. As such, it would have been obvious to one of skill in the art before the effective filing date of the claimed invention to combine the ophthalmic composition for treating dry eye comprising components (a), (b), (c) and (d)iii and iv of Coffey et al. with the ophthalmic composition for treating dry eye comprising (d)i sodium citrate and (d)ii sodium lactate taught by Beard et al., with a reasonable expectation of success. One skilled in the art before the effective filing date of the claimed invention would have been motivated to modify the ophthalmic composition of Beard et al. by incorporating the components sodium citrate and sodium lactate of the ophthalmic composition taught Coffey et al. in order to prepare an improved ophthalmic composition for treating dry eye.
Thus, claims 39, 43, 46 and 47 are prima facie obvious.
Claim 40, as amended, is drawn to claim 39, and limits wherein the antimicrobial mixture further comprises an electrolyte mixture, wherein the total electrolyte concentration in the composition comprises:
i. a potassium salt selected from potassium chloride, potassium phosphate, and mixtures thereof providing a potassium concentration of from about 24 mMol/L to about 28 mMol/L of the total composition;
ii. sodium chloride providing a sodium concentration of from about 5 mMol/L to about 10 mMol/L of the total composition; and
iii. magnesium chloride providing a magnesium concentration of from about 0.50 mMol/L to about 0.80 mMol/L of the total composition.
Claim 44 is drawn to claim 39, wherein the borate is selected from sodium borate, potassium borate, calcium borate, magnesium borate, manganese borate, and mixtures thereof.
27. Beard et al. additionally teach preferred ophthalmic compositions comprising at least one excipient in an amount of weight %/volume wherein the excipient can be: about 0.14% potassium chloride, about 0.006% magnesium chloride hexahydrate, and sodium in the form of about 0.2% w/v sodium borate decahydrate, about 0.1% w/v sodium citrate dihydrate, and/or sodium hydroxide (page 8, Table 1).
28. As such, one skilled in the art would reasonably predict that combining the salts potassium chloride, calcium chloride, magnesium chloride, and sodium in the form of sodium borate, sodium citrate or sodium hydroxide, into a single ophthalmic composition would result in an improved ophthalmic composition for treating dry eye syndrome and/or inflammation, for example.
29. And, the rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law, please see In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings). Furthermore, MPEP 2144 teaches that the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.
30. See Sundance, Inc. v. DeMonte Fabricated, Ltd., 550 F.3d 1356 (Fed. Cir. 2008): a claimed invention is obvious is it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they had been combined. And, as stated by the Court in KSR International Co., v. Teleflex Inc., 127 US 1727 (2007), “when a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious” (quoting Sakraida v. AG Pro, Inc., 425 US 273 (1976); see also: Merck v. Biocraft (874 F.2d 804, 807 (Fed. Cir. 1989), indicating that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands; Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945): indicating that “[r]eading a list and selecting a known component to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.”
31. Regarding the recited concentration(s) of potassium, sodium, magnesium, and chloride, it would have been obvious for one of ordinary skill in the art to use the starting points of about 0.14% w/v potassium chloride, about 0.006% w/v calcium chloride dihydrate, about 0.006% w/v magnesium chloride hexahydrate, and about 0.2% w/v sodium borate decahydrate, and/or about 0.1% w/v sodium citrate
disclosed by Beard et al., and optimize these amounts in an ophthalmic composition, with a reasonable expectation of success. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also 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 optimization with a reasonable expectation of success.
32. Thus, one skilled in the art would be motivated to combine the salts potassium chloride, calcium chloride, magnesium chloride, and sodium in the form of sodium borate, sodium citrate or sodium hydroxide, into the ophthalmic composition suggested by Coffey et al. in view of Beard et al., to obtain an improved ophthalmic composition, e.g., for treating dry eye syndrome and/or inflammation.
As such, claims 40 and 44 are prima facie obvious.
Claim 41 is drawn to claim 39 wherein the antimicrobial mixture further comprises ascorbic acid at a concentration not exceeding 0.001 % w/v.
33. Coffey et al. additionally suggest that the ophthalmic composition includes an anti-oxidant, specifically naming ascorbic acid (vitamin C), (see paragraph [0090]). Thus, one of skill in the art would have been motivated before the effective filing date of the claimed invention to employ the anti-oxidant ascorbic acid, for protection from oxidative damage to the eye, in an improved ophthalmic composition for treating dry eye syndrome and/or inflammation, as taught by Coffey et al. in view of Beard et al., and would have a reasonable expectation of success.
As such, claim 41 is prima facie obvious.
34. Claim 42 remains rejected under 35 U.S.C. 103 as being unpatentable over Coffey et al., U.S. 2011/0319502 A1, in view of Beard et al., CA 2898217 A1, as applied to claims 39-41, 43, 44, 46 and 47, above, and further in view of Chowhan et al., U.S. Pat. No. 5,741,817 A.
Claim 39 is addressed in detail, above.
Claim 42 is drawn to claim 39, and limits wherein the antimicrobial mixture further comprises glycine at a concentration not exceeding 0.0010 % w/v.
35. Coffey et al. in view of Beard et al. suggest an ophthalmic composition comprising (a) polyquaternium-42, (b) boric acid, (c) a polyol that is polysorbate 80 and/or glycerin, and (d) a mixture comprising a phosphate, glucose, a lactate and a citrate, but do not teach a composition comprising glycine.
36. Yet, Chowhan et al. teach the inclusion of a low molecular weight amino acid, preferably glycine, in an amount of from about 0.01 to about 2.5 w/v%, in ophthalmic compositions (e.g., for treating ocular inflammation) to enhance the overall antimicrobial activity of the composition, so as to preserve said composition from contamination (column 2, lines 21-53). Chowhan et al. specifically disclose ophthalmic formulations comprising glycine in Examples 1, 3, 5, 6 and 7 (columns 3-6).
37. Thus, one of skill in the art before the effective filing date of the claimed invention would have been motivated to include glycine in the ophthalmic composition comprising (a) polyquaternium-42, (b) boric acid, (c) polysorbate 80 and/or glycerin, and (d) a mixture comprising a phosphate, glucose, a lactate and a citrate, to enhance the overall antimicrobial activity of the composition and aid in preserving said ophthalmic composition.
38. Regarding the recited concentration of glycine, it would have been obvious for one of ordinary skill in the art to use the starting point of about 0.01% w/v to about 2.5 % w/v (column 2, lines 23-29) disclosed by Chowhan et al., and optimize these amounts for use in an ophthalmic composition, with a reasonable expectation of success. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also 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 optimization with a reasonable expectation of success.
39. As such, claim 42 is prima facie obvious.
40. Claims 45 remains rejected under 35 U.S.C. 103 as being unpatentable over Coffey et al., U.S. 2011/0319502 A1, in view of Beard et al., CA 2898217 A1 as applied to claims 39-41, 43, 44, 46 and 47, above, and further in view of Menger, Harold, J.A.M.A. 1959.
Claim 39 is addressed in detail, above.
Claim 45 is drawn to claim 39 and limits wherein the composition further comprises tetrahydrozoline or a pharmaceutically acceptable salt thereof.
41. Coffey et al. in view of Beard et al. suggest an ophthalmic composition comprising (a) polyquaternium-42, (b) boric acid, (c) a polyol that is polysorbate 80 and/or glycerin, and (d) a mixture comprising a phosphate, D-glucose, a lactate and a citrate, but do not teach a composition comprising tetrahydrozoline.
42. Yet, Menger teaches the therapeutic benefit of incorporating 0.05% tetrahydrozoline HCl into ophthalmic formulations in order to relieve redness in the eyes: “[t]etrahydrozoline hydrochloride is a sympathomimetic agent which causes local vasocontriction when topically applied… as a 0.05% solution into the eye, it was found to afford prompt relief, lasting from one to four hours,” (see the text box on page 116).
43. Thus, one of skill in the art before the effective filing date of the claimed invention would have been motivated to employ a known ophthalmic vasoconstrictor such as tetrahydrozoline HCl, with the expectation that adding a vasoconstrictor to the ophthalmic composition disclosed by Coffey et al. would necessarily aid in reducing ocular redness, and therefore would be advantageous to the desired activity of an ophthalmic composition intended to reduce redness/ inflammation or treat dry eye. One skilled in the art would readily consider combing each of the above elements in an ophthalmic composition and the composition (comprising polyquaternium-42, boric acid, polysorbate 80 and/or glycerin, and a mixture comprising a phosphate, glucose, a lactate and a citrate) would necessarily result in improved redness reduction and/or dry eye relief as taught by each of the above references.
44. In KSR International Co., v. Teleflex Inc., 127 US 1727 (2007), “when a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious” (quoting Sakraida v. AG Pro, Inc., 425 US 273 (1976); see also Merck v. Biocraft (874 F.2d 804, 807 (Fed. Cir. 1989), indicating that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands; Sundance, Inc. v. DeMonte Fabricated, Ltd., 550 F.3d 1356 (Fed. Cir. 2008): a claimed invention is obvious is it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they had been combined; Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945): indicating that “[r]eading a list and selecting a known component to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle”; Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356 (Fed. Cir. 2012): finding a “strong case of obviousness based on the prior art references of record [wherein the claim] recites a combination of elements that were all known in the prior art, and all that was required to obtain that combination was to substitute one well-known…agent for another”).
As such, claim 45 is prima facie obvious.
Response to Arguments
45. Applicant traverses the obviousness rejection, arguing that Coffey relates to pharmaceutical formulations comprising a pharmaceutically acceptable preservative and a material selected from the group consisting of D-glucose, sucrose, maltose, D-mannose, trehalose, glutamic acid, mixtures thereof, and combinations thereof, wherein the formulation has enhanced preservative efficacy against spore-forming microorganisms. Applicant argues that Beard relates to formulations and methods of using eye drop formulations comprising carboxymethyl cellulose (CMC) and hyaluronic acid (HA) with an improved distribution on the cornea during blinking; that Chowhan relates to the use of glycine and other low molecular weight amino acids in ophthalmic compositions; and that Menger teaches the use of tetrahydrozoline in managing conjunctivitis. Applicant alleges that nowhere do any of Coffey, Beard, Chowhan or Menger teach or suggest compositions combining glucose with the specifically claimed lactates and the other required components of the claims of the present invention to improve the antimicrobial activity of polyquaternium compounds incorporated into such compositions.
46. Applicant's arguments have been fully considered but they are not persuasive. In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Coffey et al. discloses a preferred ophthalmic composition for treating dry eye in Table 2, comprising 1-30 ppm polyquaternium-1, (b) 0.05-2% boric acid, (c) the polyol(s) polysorbate 80 (0.1-5%) and/or glycerin (0-3%), and (d) iii. the phosphate, 0.142% sodium phosphate dibasic anhydrous; and (d) iv. 0.1-3% D-glucose. It would have been obvious to one of skill in the art to substitute polyquaternium-42 for the polyquaternium-1 in the composition of Table 2, particularly because they are both named as suitable alternatives for benzalkonium chloride in paragraph [0032]. Beard et al. is relied upon for teaching an ophthalmic composition for treating dry eye, comprising at least one buffering agent selected from (d)i. about 0.3% sodium lactate, and (d)ii. about 0.1% sodium citrate dehydrate. Thus it would have been obvious to one of skill in the art before the effective filing date of the claimed invention to combine the components of the ophthalmic composition for treating dry eye comprising (a), (b), (c) and (d)iii and iv of Coffey et al. with the ophthalmic composition for treating dry eye comprising the components (d)i sodium citrate and (d)ii sodium lactate taught by Beard et al., with a reasonable expectation of success. Regarding claim 42, Chowhan et al. is relied upon for disclosing the advantages of including a low molecular weight amino acid, preferably glycine, in an amount of from about 0.01 to about 2.5 w/v%, in ophthalmic compositions (e.g., for treating ocular inflammation). And regarding claim 45, Menger is relied upon for teaching the therapeutic benefit of incorporating 0.05% tetrahydrozoline HCl into ophthalmic formulations in order to relieve redness in the eyes. As such, each of Coffey et al., Beard et al., Chowhan et al. and Menger is directed to an ophthalmic formulation for treating inflammation and/or dry eye, such that one of skill in the art would have been motivated to combine the components of said formulations in order to prepare an improved ophthalmic formulation for treating dry eye and/or inflammation.
47. And, the rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law, please see In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings). Furthermore, MPEP 2144 teaches that the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In the instant case, the components of known ophthalmic compositions which individually demonstrate activity for treating dry eye and/or inflammation could be combined in a composition, with the expected result of obtaining an improved ophthalmic composition suitable for treating dry eye and/or inflammation.
Please refer to MPEP 2144.06 “I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE” wherein Kerkhoven is specifically referenced:
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
As stated by the Court in KSR International Co., v. Teleflex Inc., 127 US 1727 (2007), “when a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious” (quoting Sakraida v. AG Pro, Inc., 425 US 273 (1976); see also: Merck v. Biocraft (874 F.2d 804, 807 (Fed. Cir. 1989), indicating that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands; Sundance, Inc. v. DeMonte Fabricated, Ltd., 550 F.3d 1356 (Fed. Cir. 2008): a claimed invention is obvious is it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they had been combined. Thus, absent a showing of unexpected results, the previous obviousness rejection is maintained.
Conclusion
48. In conclusion, claims 39-47 are pending. Claims 39-47 are rejected. No claim is currently allowable.
49. THIS ACTION IS MADE FINAL. 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.
50. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached on Monday-Friday 8:30AM-5PM EST.
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/JANET L COPPINS/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628