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 .
Formal Matters
Claims 1-19 were originally presented on 12/14/2022. The preliminary amendments to the claims, also filed on 12/14/2022, have been received and entered. Claim 20 was newly added.
Claims 1-20 are pending and under examination.
Priority
This application is a U.S. national stage entry of PCT international application no. PCT/CN2021/073733, filed on January 26, 2021, which claims priority to Chinese Patent Applications with the application numbers 202010564049.5, 202010562124.4, 202010562090.9, 202010561406.2 and 202010561395.8, filed on June 18, 2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
Applicant’s Information Disclosure Statements filed 12/14/2022, 11/20/2023, and 05/01/2025 have been received and entered into the present application. As reflected by the attached, completed copies of form PTO-1449, the Examiner has considered the cited references to the extent that they comply with the provisions of 37 C.F.R. §1.97, §1.98 and MPEP §609.
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.
"The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicants regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.", (see MPEP § 2173).
Claims 1-4 and 7-20 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.
Claim 1 recites component A which is a substance having a group represented by Formula I:
PNG
media_image1.png
140
194
media_image1.png
Greyscale
The claims are indefinite under 35 U.S.C. 112(b) because the metes and bounds of the claimed Formula I are not clearly defined. Specifically, the cycle connecting sulfur and nitrogen atoms of the heterocyclic ring system is not defined. Additionally, it is unclear what connections, if any, are intended to be attached to the C=O and -COO groups. For example, the open-ended line could be construed to represent a methyl group and not a bond to another chemical moiety.
Additionally, the claims are unclear because it is not readily apparent what “a component A” is comprised of. Claim 1 recites “…comprising a component A which is a substance having a group represented by the Formula I below and a surfactant…”. This limitation could be construed in two different ways having completely different scope because of the lack of commas in the limitation. One interpretation is that component A refers to both a substance having a group represented by the Formula I and a surfactant, i.e., Component A = Formula I + surfactant. Another possible interpretation is that component A is intended to mean only Formula I and the surfactant is a separate “component” of the hydrate promoter, i.e., Component A = Formula I. If this were the case, the limitation should have additional commas, i.e., “…comprising a component A, which is a substance having a group represented by the Formula I below, and a surfactant…”. In some dependent claims, Applicants refer only to “the component A” rendering it unclear what is actually being referred to in these claims. If it is Applicant’s intent that “component A” is synonymous with a substance having a group represented by the Formula I, claim 1 would be more clear if it simply recited “…comprising a substance having a group represented by the Formula I below and a surfactant…” or if commas were added to the limitation, i.e., “…comprising a component A, which is a substance having a group represented by the Formula I below, and a surfactant…”.
Claim 8 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 8 recites the limitation “Tween series polyol type nonionic surfactant”. Claim 8 therefore contains the trademark/trade name “Tween”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a particular polyol type nonionic surfactant product and, accordingly, the identification/description is indefinite.
Additionally, claim 8 recites the limitation "wherein the component A is selected from the cephalosporin compounds" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 8 depends from claim 7, which depends from claim 1. Claim 1 recites component A is a substance having a group represented by Formula I, which are not limited to “cephalosporin compounds”. As such, it is unclear what “the cephalosporin compounds” recited in claim 8 is referring to.
Claims 9-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the limitation "wherein the component A is selected from the penicillin compounds" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 9 depends from claim 7, which depends from claim 1. Claim 1 recites component A is a substance having a group represented by Formula I, which are not limited to “penicillin compounds”. As such, it is unclear what “the penicillin compounds” recited in claim 9 and claims dependent therefrom is referring to.
Claims 13-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 recites the limitation “…the anti-agglomerant is selected from the statin organics, preferably at least one selected from the group consisting of pravastatin, lovastatin, simvastatin, and atorvastatin”. The metes and bounds of the claims are unclear because it not clear whether the statin organics are intended to be limited to only the recited “preferably” embodiments. Specifically, the phrase "preferably" is construed similarly to “for example”, “or the like”, and “such as” and therefore renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 15 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 15 recites the limitation "optionally the adjuvant contained in the hydrate promoter" in line 6. There is insufficient antecedent basis for this limitation in the claim. Claim 15 depends directly from claim 1 which recites a hydrate promoter comprising a component A and a surfactant. Nowhere does claim 1 recite an adjuvant as component or optional component of the hydrate promoter. As such, it is unclear what “the adjuvant contained in the hydrate promoter” recited in claim 15 is referring to.
Claim Rejections - 35 USC § 112(a) (Written Description)
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 and 7-20 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.
Independent claim 1 recites a component A having a group represented by Formula I:
PNG
media_image1.png
140
194
media_image1.png
Greyscale
This partial structure is not fully described anywhere in the disclosure. Specifically, Applicants disclose that the reference signs “—" are chemical bonds instead of methyl (Specification at [0023]), but do not disclose or describe what these are chemical bond to. Applicants further disclose that the cyclic structure having N and S in Formula I “may have other substituted groups, and the positions of substitution may have many options” (Specification at [0025]), but do not disclose or describe what these other substituted groups are. Applicants disclose “cephalsporins” of Formula II and “penicillins” of Formula III at [0028]).
PNG
media_image2.png
118
348
media_image2.png
Greyscale
. They disclose that the reference signs “—” marked by 3, 4, 5 are chemical bonds, instead of methyl in Formula II and the reference signs “—” marked by 6, 7 are chemical bonds, instead of methyl in Formula III (Specification at [0030]).
PNG
media_image3.png
120
140
media_image3.png
Greyscale
PNG
media_image4.png
114
156
media_image4.png
Greyscale
Here too, Applicants do not disclose or describe what the reference signs “—" are chemically bonded to.
Applicants disclose and claim 9 species of cephalosporin antibiotics (Table I; [0033]; Claim 5) and 6 species of penicillin antibiotics (Table II; [0038]; Claim 6). These species, however, are not at all “representative” of the broadly claimed genus of Formula I, which is essentially limitless in scope because Applicants do not disclose or describe any substituents that may be present thereon, either at the reference signs “—” or on the cyclic structure having N and S.
A person of ordinary skill in the art would not be able to predict the operability of any given compound falling within the scope of Formula I to promote the nucleation and growth of a gas hydrate. While Applicants allege that the desired inventive effect can be obtained as long as the substance having the group represented by Formula I and the surfactant are combined in a specific ratio, Applicants only disclose a hydrate promoters obtained by mixing penicillin sodium, penicillin potassium, carbenicillin sodium, oxacillin sodium, or ampicillin sodium (Examples 1-13; 33) or monohydrate cefchlorampin, cefalexin, cefotaxime, or cefadroxil (Examples 14-31; 34) with specific surfactants in specific ratios.
Accordingly, the disclosure as filed lacks written description of the claimed compounds of Formula I because Applicants do not disclose or describe the substituents that may be present thereon, e.g., at the reference signs “—” or on the cyclic structure having N and S.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Regarding the below rejections under 35 U.S.C. 102, the recited intended use as a “hydrate promoter” is not a limiting feature of the composition of claim 1. Any composition comprising a compound of formula I and a surfactant in the claimed molar ratio is construed to be suitable as a hydrate promoter absent factual evidence to the contrary.
Claim(s) 1-5 and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2015/147279 A1 (Published May 28, 2015) (Cited by Applicants in IDS filed 11/20/2023).
Example 2 of US ‘279 teaches a composition comprising 21% of Cefaclor [Cefaclor belongs to the claimed class of cephalosporins] and 14% of a surfactant [ratio 3:2]. It teaches the surfactant can be selected from a group comprising sodium lauryl sulfate, sodium sulfate anhydrous and magnesium lauryl sulfate ([0093]). Regarding claim 5, it teaches the cephalosporin is a second generation cephalosporin, including cefoxitin, cefamandol, cefotetan, cefuroxime, cefprozil and cefaclor, preferably cefaclor, cefprozil, cefuroxime ([0083]).
Claim(s) 1-4, 7, and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 109908079 A (Published June 21, 2019) (Cited by Applicants in IDS filed 11/20/2023).
CN ‘079 teaches oral solutions comprising cefaclor, which is a compound represented by Formulas I and II as required by claims 1, 3-4, and 20 and belongs to the claimed class of cephalosporins ([0002] of Applicant provided English translation):
PNG
media_image5.png
140
248
media_image5.png
Greyscale
. The compositions comprise 40-60 parts by weight cefaclor and 10-20 parts by weight of surfactant (Claim 1). Regarding claims 1-4, 7, and 19-20, Example 7 teaches a composition comprising 50 parts by weight cefaclor and 12 parts by weight Tween 80 [mass ratio of 1:0.24 as required by claim 2]. Converted to moles, this is a molar ratio of 1:15 as required by claim 1. Tween 80 is a nonionic surfactant” as recited in claim 7.
Claim(s) 1-4, 6-7, and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 108770836 A (Published June 9, 2010) (Cited by Applicants in IDS filed 12/14/2022).
CN ‘836 teaches liquid-based cell preservation solutions comprising the following components in parts by weight: 17 parts ethanol, 3 parts EDTA disodium dihydrate, 7 parts sodium acetate buffer, 0.5 parts NaCl, 7 parts ampicillin, 0.06 parts N-acetyl-L-cysteine, and 3 parts Tween-20 (Description; Embodiment 4). Ampicillin is a penicillin antibiotic of formula I, i.e., “ampicillin class”, as required by claims 1, 3-4, 6, and 20:
PNG
media_image6.png
232
434
media_image6.png
Greyscale
. Upon conversion to moles, the molar ratio of ampicillin to Tween-20 is about 1:8.569 as required by claim 1. On a mass basis, the ratio of ampicillin to Tween-20 is about 1:2.33 as required by claim 2. Tween-20 is a non-ionic surfactant as required by claim 7.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-7 and 19-20 are rejected under 35 U.S.C. 103(a) as being unpatentable over US 2015/147279 A1 (Published May 28, 2015), CN 109908079 A (Published June 21, 2019), and CN 108770836 A (Published June 9, 2010).
Example 2 of US ‘279 teaches a composition comprising 21% of Cefaclor [Cefaclor belongs to the claimed class of cephalosporins] and 14% of a surfactant [ratio 3:2]. It teaches the surfactant can be selected from a group comprising sodium lauryl sulfate, sodium sulfate anhydrous and magnesium lauryl sulfate ([0093]). Regarding claim 5, it teaches the cephalosporin is a second generation cephalosporin, including cefoxitin, cefamandol, cefotetan, cefuroxime, cefprozil and cefaclor, preferably cefaclor, cefprozil, cefuroxime ([0083]).
CN ‘079 teaches oral solutions comprising cefaclor, which is a compound represented by Formulas I and II as required by claims 1, 3-4, and 20 and belongs to the claimed class of cephalosporins ([0002] of Applicant provided English translation):
PNG
media_image5.png
140
248
media_image5.png
Greyscale
. The compositions comprise 40-60 parts by weight cefaclor and 10-20 parts by weight of surfactant (Claim 1). Regarding claims 1-4, 7, and 19-20, Example 7 teaches a composition comprising 50 parts by weight cefaclor and 12 parts by weight Tween 80 [mass ratio of 1:0.24 as required by claim 2]. Converted to moles, this is a molar ratio of 1:15 as required by claim 1. Tween 80 is a nonionic surfactant” as recited in claim 7.
CN ‘836 teaches liquid-based cell preservation solutions comprising the following components in parts by weight: 17 parts ethanol, 3 parts EDTA disodium dihydrate, 7 parts sodium acetate buffer, 0.5 parts NaCl, 7 parts ampicillin, 0.06 parts N-acetyl-L-cysteine, and 3 parts Tween-20 (Description; Embodiment 4). Ampicillin is a penicillin antibiotic of formula I, i.e., “ampicillin class”, as required by claims 1, 3-4, 6, and 20:
PNG
media_image6.png
232
434
media_image6.png
Greyscale
. Upon conversion to moles, the molar ratio of ampicillin to Tween-20 is about 1:8.569 as required by claim 1. On a mass basis, the ratio of ampicillin to Tween-20 is about 1:2.33 as required by claim 2. Tween-20 is a non-ionic surfactant as required by claim 7.
It would have been obvious to a person of ordinary skill in the art before the filing date of the instant application to make a composition comprising a compound of Formula I (e.g., a penicillin or cephalosporin antibiotic) and a surfactant in the claimed molar/mass ratios. Indeed, each of the cited references expressly teaches such compositions. Accordingly, the Examiner finds that the combined teachings of the cited prior art expressly teach compositions falling within the scope of the present claims. The recited intended use as a “hydrate promoter” is not a limiting feature of the composition of claim 1 and claims dependent therefrom. Any composition comprising a compound of formula I and a surfactant in the claimed molar ratio, such as those taught in the cited prior art, is construed to be suitable as a hydrate promoter absent factual evidence to the contrary.
Conclusion
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES D ANDERSON whose telephone number is (571)272-9038. The examiner can normally be reached on Monday-Friday, 7:30 am - 4:00 pm PST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/James D. Anderson/Primary Examiner, Art Unit 1629
UNITED STATES PATENT AND TRADEMARK OFFICE
Tel. No.: (571) 272-9038