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 .
The Applicants’ Amendment to the Claims filed on January 27, 2016 is entered.
The Applicants’ Amendment to the Specification filed on January 27, 2016 is entered.
Claims 3-4, 11-13, and 16-20 are cancelled.
Claims 21-23 are new.
Claims 1, 2, 5-10, 14, 15, and 21-23 are pending and under examination.
This US 18/030,352 filed on 04/05/2023 which is a 371 of PCT/EP2021/077409 filed on 10/05/2021 claims foreign priority to UNITED KINGDOM 2015836.6 filed on 10/06/2020. The Filing Receipt filed on August 16, 2023 is controlling.
Response to Amendments
All objections and rejection made in the previous office action and not repeated in this office action are withdrawn in view of the Applicants’ submission filed on January 27, 2016.
Information Disclosure Statement
The IDS statement filed on February 19, 2026 have been considered by the examiner.
Claim interpretation
As described in the Specification, the term water-free or substantially anhydrous is construed to mean that there is an insufficient number or concentration of water molecules to form bulk water, such as a water droplet. As described in the specification in paragraph bridging pages 4-5, water molecules can be present in the composition as long as there in not sufficient water to form bulk water. The specification notes that the water content of the composition may be below about 1% w/w water with respect to other components.
Claim Objections
Claims 6-8 are objected to because of the following informalities: Claims 6-8 recite “active fragment or active variant” whereas the presently amended base claim 1 recites “active fragments or active variants”. The claims should be amended to recite either all singular terms “fragment”, “variant” or to recite all plural terms “fragments”, “variants”. Appropriate correction is required.
Claim Rejections - 35 USC § 112 – new grounds necessitated by amendment
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.
Currently amended claims 1, 2, 5-10, 14, 15, and 21-23 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 …"wherein the polypeptide is natural alpha-lactalbumin, or active fragments or active variants thereof, wherein the active fragments or variants thereof are derived from the alpha-helical domain of natural alpha- lactalbumin…”. The scope of the structure required by the term “derived from” is unclear.
Also, regarding claim 8, the phrase "preferably" 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).
Claims 2, 5-7, 9-10, 14, 15, and 21-23 are indefinite because they depend from claim 1 and are not remedial. Note that claim 8 is remedial because it specifies the structure.
The following is a quotation of 35 U.S.C. 112(d): – new grounds necessitated by amendment
(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.
Claim 14 is 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. Claim 14 fails to include all the limitations of claim 1. Claim 14 depends from claim 1 but does not explicitly recite requiring the method of claim 1. Claim 14 recites providing a composition obtained by a method according to claim 1. 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.
Claim Rejections - 35 USC § 103– new grounds necessitated by amendment
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 5-10, 14, 15, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over WO-2018/210759A1 to Nadim & Svanborg (published November 22, 2018; of record, IDS ref), in view of McGrath et al (US2019/0247469 published August 15, 2019), in further view of Das et al (WO-02/08401 A2 published January 31, 2002; equivalent to AU 2001277982 A1 published May 2, 2002).
Regarding claims 1 and 9-10, Nadim & Svanborg teach a method for preparing a composition, the method comprising the steps of combining:
a. a dried polypeptide, specifically an α-lactalbumin (see Abstract),
b. a pharmaceutically acceptable salt of oleic acid (see Abstract), and
c. a buffer component comprising at least two salts, wherein the first salt is sodium or potassium chloride and the second salt is disodium phosphate or mono-potassium phosphate. Regarding claim 1 (b), note that the structure of oleic acid is C18H34O2. Oleic acid meets the limitation that the fatty acid or lipid is a cis C18:1:9 or C18:1:11 fatty acid. Further, regarding claim 1, part (c), Nadim & Svanborg discloses that the buffer component comprises a PBS buffer. For example, see page 2, lines 27-30 which recites:
Thus, it is clear that complexes of this type rely on the presence of salts in their production. Phosphate buffered saline (PBS) as used previously, comprises a mixture of at least three and sometimes four salts. These are sodium chloride, disodium phosphate and mono-potassium phosphate, as well as in some cases also, potassium chloride.
Regarding claims 2 and 21, Nadim & Svanborg discloses that the buffer component further comprises a third salt which is mono-potassium phosphate. For example, see page 2, lines 27-30 which recites:
Thus, it is clear that complexes of this type rely on the presence of salts in their production. Phosphate buffered saline (PBS) as used previously, comprises a mixture of at least three and sometimes four salts. These are sodium chloride, disodium phosphate and mono-potassium phosphate, as well as in some cases also, potassium chloride.
Regarding claim 5, Nadim & Svanborg discloses that the polypeptide is a natural human or bovine alpha-lactalbumin. Note that claim 5 depends from claim 1 and alpha-lactalbumin is written in the alternative. Further, Nadim & Svanborg in Example 1 discloses a lyophilized fragment of unfolded human alpha-lactalbumin, identical to SEQ ID NO: 6 of the present application, in a mixture with sodium oleate flakes, solubilized in several different buffers, some of them being PBS.
Regarding claims 6-8, note that in the base claim 1, the limitation of fragment or variant is written in the alternative to wherein the polypeptide is natural alpha-lactalbumin. Since claims 6-8 do not select the type of polypeptide, these claims read on the alternative of wherein the polypeptide is natural alpha-lactalbumin and limitations to the fragment or variant are not required for purpose of applying prior art. Further, Nadim & Svanborg in Example 1 discloses a lyophilized fragment of unfolded human alpha-lactalbumin, identical to SEQ ID NO: 6 of the present application.
However, instant claims differ from patented claims because they do not specify that the composition of alpha-lactalbumin, oleic acid, and buffer salts is not in an aqueous phase and is not subjected to a drying step.
McGrath et al discloses a method for preparing a composition, the method comprising combining a dried natural alpha-lactalbumin, an oleic acid or pharmaceutically acceptable salt thereof, and at least two salts including sodium or potassium chloride and mono-potassium phosphate, where the composition is not in an aqueous phase and is not subjected to a drying step before adding a diluent such as sterile water. McGrath et al discloses that it is prima facie obvious to make a therapeutic or nutritional composition by combining alpha-lactalbumin, oleic acid, and salts in a dry composition before adding a diluent such as sterile water. McGrath et al discloses nutritional food compositions such as infant formulas that contain alpha-lactalbumin and oleic acid. McGrath et al discloses that these nutritional compositions contain multiple kinds of salts including potassium chloride, calcium phosphate, and magnesium phosphate. (See ref claim 10). McGrath et al teach a method for preparing a composition which is a nutritional formula, the method comprising the steps of combining: a. a dried polypeptide, specifically an α-lactalbumin (see Abstract), b. a pharmaceutically acceptable salt of oleic acid (see Abstract), and c. a buffer component comprising at least two salts, wherein the first salt is potassium chloride (see para 103; ref claim 10) and the second salt is dicalcium phosphate (see Table 001-002), wherein the composition is not is an aqueous phase and is not subjected to a drying step. Regarding claim 1 (b), note that the structure of oleic acid is C18H34O2. Oleic acid meets the limitation that the fatty acid or lipid is a cis C18:1:9 or C18:1:11 fatty acid. See Abstract just below:
The present disclosure provides a nutritional formula comprising alpha-lactalbumin enriched whey protein concentrate; beta-casein enriched milk protein; mildly hydrolyzed milk protein; osteopontin; lactoferrin; oleic acid-palmitic acid-oleic acid triglyceride, wherein palmitic acid is at the SN-2 position of the glycerol backbone of the triglyceride; lactose, wherein the lactose is reduced lactose; lutein; docosahexanoic acid; arachidonic acid; galactooligosaccharides; and polydextrose. The provided nutritional formulas may be useful in providing nutrition and/or promoting postnatal development of a subject (e.g., promoting postnatal development of an infant's gastrointestinal functions, nutrient absorption, immune system development, etc.). Also provided are powder forms, reconstituted formulas, kits, methods, and uses that include or involve a nutritional formula described herein.
Further, although McGrath et al does not specify disodium phosphate, Das et al disclose that disodium phosphate is a standard ingredient in a nutritional formula.
Das et al teach a method for preparing a nutritional composition, including an infant formula, the method comprising the steps of combining: a dried polypeptide, specifically milk whey proteins, oleic acid, and salts including potassium chloride, sodium chloride, disodium phosphate and mono-potassium phosphate wherein the composition is not is an aqueous phase and is not subjected to a drying step. See Section E and which discloses nutritional formula ingredients comprising whey protein , high-oleic safflower oil, sodium chloride, potassium chloride, disodium phosphate (aka sodium phosphate dibasic), and mono-potassium phosphate (aka potassium phosphate monobasic). (See Sections A; D; G).
Further, regarding amended claims 14-15, and 22-23, McGrath et al disclose a dry powder nutritional composition being reconstituted in water as an aqueous carrier (for example infant formula reconstituted with water). Reconstitution of dry nutritional formula in water involves agitating the mixture at room temperature which meets the limitations of moderate or ambient temperature and as carried out at 10-40°C.
The level of skill in the art of making nutritional and therapeutic compositions containing alpha-lactalbumin and oleic acid was high before the effective filing date of the presently claimed invention.
One of ordinary skill in the art would have been motivated to combine alpha-lactalbumin and oleic acids with salts in a dry phase before reconstituting with liquid such as sterile water for the rationale of providing a pharmaceutical or nutritional composition with better stability and for better storage.
In view of the high skill level in the art before the effective filing date of the presently claimed invention it is considered that one would have a reasonable expectation of success to combine the known elements of alpha-lactalbumin, oleic acid, and standard buffer salts found in the standard PBS buffer used for pharmaceuticals and used in dry powder infant formula preparations to arrive at the presently claimed invention.
Double Patenting – new grounds necessitated by amendment
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Currently amended claims 1, 2, 5-10, 14, 15, and 21-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,331,073 B2 in view of McGrath et al (US2019/0247469 published August 15, 2019). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims in combination with McGrath et al render obvious the present claims.
Regarding presently amended claims 1, and 5-10, patented claim 1 recites: a method for preparing a biologically active complex, said method comprising dissolving a mixture of a polypeptide element in powder form and oleic acid or a pharmaceutically acceptable salt thereof also in solid form, in an aqueous solvent comprising at least two salts to form an aqueous solution comprising a biologically active complex of the polypeptide element and oleic acid, wherein the first salt of the at least two salts is sodium chloride or potassium chloride and the second salt of the at least two salts is disodium phosphate or mono-potassium phosphate, wherein the method is performed at a moderate temperature of up to 50° C., and wherein the polypeptide element is:
(a) an alpha-lactalbumin or an alpha-lactalbumin having each of the cysteine residues replaced with another amino acid; or
(b) a peptide fragment of an alpha-lactalbumin having up to 50 amino acids and comprising SEQ ID NO:1, SEQ ID NO:2, SEQ ID NO:6 or SEQ ID NO:7.
Regarding instant claims 2, and 21, patented claims 2 and 11 recite a third salt which is mono-potassium phosphate.
Regarding amended instant claims 14-15, and 22-23, patented claims 1, 3-4 recite providing a composition of claim 1, adding an aqueous carrier, and agitating the mixture at moderate, or ambient temperature, or 10-40 degree C.
However, instant claims differ from patented claims because they do not specify that the composition of alpha-lactalbumin, oleic acid, and buffer salts is not in an aqueous phase and is not subjected to a drying step.
McGrath et al discloses that it is prima facie obvious to make a therapeutic or nutritional composition by combining alpha-lactalbumin, oleic acid, and salts in a dry composition before adding a diluent such as sterile water. McGrath et al discloses nutritional food compositions such as infant formulas that contain alpha-lactalbumin and oleic acid. McGrath et al discloses that these nutritional compositions contain multiple kinds of salts including potassium chloride, calcium phosphate, and magnesium phosphate. (See ref claim 10). McGrath et al teach a method for preparing a composition which is a nutritional formula, the method comprising the steps of combining: a. a dried polypeptide, specifically an α-lactalbumin (see Abstract), b. a pharmaceutically acceptable salt of oleic acid (see Abstract), and c. a buffer component comprising at least two salts, wherein the first salt is potassium chloride (see para 103; ref claim 10) and the second salt is dicalcium phosphate (see Table 001-002), wherein the composition is not is an aqueous phase and is not subjected to a drying step. Regarding claim 1 (b), note that the structure of oleic acid is C18H34O2. Oleic acid meets the limitation that the fatty acid or lipid is a cis C18:1:9 or C18:1:11 fatty acid. See Abstract just below:
The present disclosure provides a nutritional formula comprising alpha-lactalbumin enriched whey protein concentrate; beta-casein enriched milk protein; mildly hydrolyzed milk protein; osteopontin; lactoferrin; oleic acid-palmitic acid-oleic acid triglyceride, wherein palmitic acid is at the SN-2 position of the glycerol backbone of the triglyceride; lactose, wherein the lactose is reduced lactose; lutein; docosahexanoic acid; arachidonic acid; galactooligosaccharides; and polydextrose. The provided nutritional formulas may be useful in providing nutrition and/or promoting postnatal development of a subject (e.g., promoting postnatal development of an infant's gastrointestinal functions, nutrient absorption, immune system development, etc.). Also provided are powder forms, reconstituted formulas, kits, methods, and uses that include or involve a nutritional formula described herein.
One of ordinary skill in the art would have been motivated to make the composition of the patented claims in a dry form before reconstituting in sterile water for the rationale of keeping stability, or storage. In view of the high skill level in the art before the effective filing date of the presently claimed inventio it is considered that one would have a reasonable expectation of success to combine the known elements of alpha-lactalbumin, oleic acid, and buffer salts found in the standard PBS buffer before adding a diluent such as sterile water to arrive at the presently claimed invention.
Conclusion
No claim is 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 CATHERINE S HIBBERT whose telephone number is (571)270-3053. The examiner can normally be reached M-F 8:00-5:00.
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, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CATHERINE S. HIBBERT
Primary Examiner
Art Unit 1658
/CATHERINE S HIBBERT/Primary Examiner, Art Unit 1658
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