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 .
Notice of Pre-AIA or AIA Status
DETAILED ACTION
Status of the Claims
Claims 17-20 are new. Claims 1-20 are pending. Claims 1-15 are withdrawn. Claims 16-20 are under examination.
Priority
This application is a national stage entry of PCT/EP2021/086775 filed on 12/20/2021, which claims priority from European application EP20383132.6 filed on 12/21/2020.
Rejections Withdrawn
The rejections under USC 112(b) over claim 16 are withdrawn per applicant’s amendments.
As these rejections are withdrawn, applicant’s arguments toward these rejections are now moot.
New Objection – As Necessitated by Amendment
Claim 16 is objected to for “when administer to a patient” which is more grammatically correct as “when administered to a patient”. Appropriate correction is required.
New Rejections – As Necessitated by Amendment
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 17-20 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.
Claims 17-20 recite the limitation "The water-based salt composition”, but the prior recitation is to “A water-based salt solution composition”, where a solution is more particular form of composition. It is not clear if this has to be directed to “A water-based salt solution composition” or may be directed to any forms that are not solutions. Applicant does not have antecedent basis to composition that is possibly not in solution form. There is insufficient antecedent basis for this limitation in the claim. Applicant may amend the claims to say “The water-based salt solution composition”.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 17-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The preambles of these claims provide for “The water-based salt composition” where claim 16, on which they depend, indicates that it is “A water-based salt solution composition”, which is defined by solution form. The use of the broader “composition” without having “solution” can potentially extend the claims to other non-solution forms of compositions (e.g. suspensions). Thus, they are not further limiting in this regard. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Applicant may amend these claims to indicate “The water-based salt solution composition…” so they can clearly be solution compositions.
Maintained Rejection – Modified To Mention Amendments/New Claims
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Meier WO2018206357A1 (English translation from family document US 20210137968A1) and European Pharmacopoeia (4.1.3- Buffer solutions, 1/2005, pages 430-435).
Applicant amends the preamble of claim 16 to include “for promoting mucosal re-epithelization”. This is an intended use with the preamble of the claim, which is to a solution (see MPEP 2111.02). The applicant’s claim remains to “A water-based salt solution” and is not a method of using/treating claim.
Applicant amends and indicates “comprising as active ingredients” before the recitations of the list of ingredients. If the prior art teaches these compounds and allows for such amounts, it will teach the active ingredients of the claim whether the art recognized them for this use or not.
Applicant includes a clause to “wherein the active ingredients of the water-based salt solution promote mucosal re-epithelization when administer(ed) to a patient”. Again, if the prior art teaches combining such ingredients in such amounts of the claim, it will teach these limitations.
Applicant adds claims 17-20 to move items that were listed with “particularly” or “optionally” to new dependent claims. If the prior art taught those limitations, it will continue to teach those limitations.
Meier teaches a composition with chondroitin sulfate (active), hyaluronic acid (active) and a dihydrogen phosphate/monohydrogen phosphate buffer system and optionally at least one physiologically compatible electrolyte (paragraphs 67-72). Meier teaches the pH being between 6.1 to 7.9 (paragraph 72). Meier teaches alkali metal dihydrogen phosphates (paragraphs 142-146). Meier teaches pH from 7.1 to 7.4 (paragraph 148). Meier teaches sodium dihydrogen phosphate (paragraphs 132-133). Meier teaches sodium and/or potassium as options for the alkali metal (paragraphs 131 and 226). Meier teaches alkali metal salts including sodium chloride as an electrolyte (paragraphs 228 and 252). Meier teaches composition A1 with chondroitin sulfate sodium, sodium hyaluronate, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride and water (paragraph 258). Water serving as the carrier. Meier teaches calcium and/or magnesium salt (paragraph 174). Meier teaches “a total concentration of alkali metal dihydrogen phosphate/alkali metal monohydrogen phosphate buffer system of (1.75±1.65) mg/ml” (paragraphs 142-146). As applicant’s claimed range for sodium dihydrogen phosphate would cover concentrations of 0.96 mg/ml to 1.44 mg/ml (8 mM to 12 mM), the range of Meier overlaps as it would cover from 0.1 to 3.4 mg/ml. Meier teaches pharmaceutical compatible carrier (excipient) (paragraph 164). The concentration of sodium chloride in Composition A1 of Meier equates to 135 mM sodium chloride. Meier does provide for treatment of inflammatory diseases with administration of its formulations and for pharmaceutical compositions (abstract).
Meier does not teach a composition with the concentrations of potassium dihydrogen phosphate, calcium chloride, potassium chloride and magnesium chloride as in applicant’s claims.
European Pharmacopoeia teaches a buffer composition with pH 7.2 with 8 g sodium chloride, 0.2 g potassium chloride, 0.1 g anhydrous calcium chloride, 0.1 g magnesium chloride, 3.18 g disodium hydrogen phosphate and 0.2 g potassium dihydrogen phosphate in 1000 ml water (page 432, buffered salt solution pH 7.2). The amounts correspond to 136.9 mM sodium chloride, 2.68 mM potassium chloride, 0.901 mM calcium chloride, 1.05 mM magnesium chloride and 1.47 mM potassium dihydrogen phosphate.
One of ordinary skill in the art before the time of filing would have included the amounts of potassium dihydrogen phosphate, potassium chloride, calcium chloride and magnesium chloride into buffer solutions of Meier, which includes these ingredients, as they are recognized amounts of such pharmaceutical buffer components for making a composition with pharmaceutical buffer with dihydrogen phosphate that offers a pH 7.2 in European Pharmacopeia, which is within Meier’s pH range for its buffered pharmaceutical composition.
Response to Applicant’s Arguments to the Rejection under USC 103
Applicant has amended the claims to provide limitations to provide the listed components as active ingredients and that wherein the active ingredients promote mucosal re-epithelization when administered to a patient. Applicant argues that the prior art does not note the agents it teaches that are of the applicant’s claims as being active ingredients for the activity of promoting mucosal re-epithelization. The examiner disagrees. In the preamble, “for promoting mucosal re-epithelization” is toward the intended use of the composition (see MPEP 2111.02). The prior art of Meier teaches these agents for aqueous solutions that are acceptable for treating subjects. Further European Pharmacopoeia provides agents and concentrations for a pharmaceutical buffer. Therefore, these agents in the prior art were being combined into aqueous solutions in overlapping amounts/concentrations for the treatment of patients and such effects would have arisen from solutions/compositions motivated by these teachings. Furthermore, applicant’s claim is to a composition/solution and not to a method of treating where the solution has to be administered to a subject in need thereof. The prior art only needs to teach the composition structure and components to teach this composition claim.
In response to applicant's argument that the composition should receive benefit for “for promoting mucosal re-epithelization”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant argues that at best, the prior art (Meier or European Pharmacopeia) teaches its buffer components have no therapeutic effect and would be therapeutically neutral. Again, these claims are to a composition of matter for pharmaceutical use and the prior art allows for compositions with the claimed ingredients in overlapping amounts with applicant’s claims in an aqueous solution form. The prior art purposes for its ingredients do not have to be the same as applicant’s intended utility for the ingredients. In MPEP 2141- (“[I]t is not necessary in order to establish a prima facie case of obviousness that both a structural similarity between a claimed and prior art compound (or a key component of a composition) be shown and that there be a suggestion in or expectation from the prior art that the claimed compound or composition will have the same or a similar utility as one newly discovered by applicant”) (emphasis added); In re Lintner, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972) (“The fact that appellant uses sugar for a different purpose does not alter the conclusion that its use in a prior art composition would be prima facie obvious from the purpose disclosed in the references.”).
Applicant argues that Meier alone or in combination with European Pharmacopeia does not teach or suggest mucosal re-epithelization. As explained above, the prior art uses for its ingredients in this composition claim do not have to have the same intended use or be recognized for the same functions. This claim is not to a method of treating a patient in need of mucosal re-epithelization with an administering step to the patient.
Applicant argues that Meier already provides a preferred formulation and there would be no reason to modify based on European Pharmacopeia with teaching a buffered salt solution of pH 7.2. First, it is notable that European Pharmocopeia is used to provide concentrations of the prior art for all ingredients taught in Meier. Meier teaches “a dihydrogen phosphate/monohydrogen phosphate buffer system and optionally at least one physiologically compatible electrolyte (paragraphs 67-72)”, and thus, one of ordinary skill in the art will look to other pharmaceutically acceptable buffer systems and compatible electrolytes provided in the prior art for their teachings. Thus, European Pharmacopeia provides for concentrations known for ingredients in such buffering systems (see MPEP 2144.05). Additionally, one of ordinary skill in the art would routinely use agents of the prior art with an art recognized suitability for an intended purpose (See MPEP 2144.07). In this case the art recognized suitability is for pharmaceutical buffering systems that would support administration of such a formulation.
Thus, the prior art provides the teachings of pharmaceutical formulations having the claimed ingredients and concentrations in aqueous solution form through motivations of the prior art and the prior art combination provides a reasonable expectation of success in producing the composition of matter in applicant’s claim.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARK V STEVENS/Primary Examiner, Art Unit 1613
Prosecution Insights