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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 20 May 2025 has been entered.
Status of the Claims
Claims 1-60 were originally filed 5 March 2021 and the preliminary amendment filed the same day has been entered. Currently claims 1-3, 6-13, 35-36, 40, 41, 43, 44, 48, 60, and 61 are currently pending and under consideration.
Priority
The instant application claims priority to PCT/US2019/049709 filed 5 September 2019 US Provisional Applications 62/780,544 filed 17 December 2018 (referred to herein as ‘544 application) and 62/727,345 filed 5 September 2018 (referred to herein as ‘345 application).
It is noted the ‘345 provisional application does not disclose or contemplate the following:
A stabilized prophylactic and/or therapeutic formulation wherein the one or more stabilizing agents is α-lactalbumin or myristyl sulfobetaine (claim 1),
A stabilized prophylactic and/or therapeutic formulation wherein said histidine buffering agent pH 6.0±0.2 (claim 44), or
A stabilized prophylactic and/or therapeutic formulation wherein said formulation is administered as a probiotic supplement (see claim 61).
It is noted the ‘544 application does not disclose or contemplate the following:
A stabilized prophylactic and/or therapeutic formulation wherein said formulation is administered as a probiotic supplement (see claim 61)
Therefore, the priority date for the instant claims 1 and 44 is that of the ‘544 provisional application filed 17 December 2018 and clam 61 is that of the PCT/US2019/049709 filed 5 September 2019.
Specification
The use of the term “pluronic F-68”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Drawings
The drawings are objected to because Figure 3 is missing. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Withdrawn Objections
In view of Applicant amending claims 1, 7, 11, and 41 to address the claim objections said claim objections are hereby withdrawn.
Withdrawn Rejections
In view of Applicant amending claim 40 to remove “polyoxyethylene-polyoxypropylene block copolymer” the 35 U.S.C. 112(a) rejection (New Matter) is hereby withdrawn.
Maintained Rejections
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 (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 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.
Claims 1-3, 6-9, 35, 36, 40, 41, 43, 44, 48, 60, and 61 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Enfamil® (as cited on the PTO-892 dated 21 November 2024) as evidenced by Andreas, Zhang, Kim, and The Washington State Department of Health (as cited on PTO-892 dated 21 March 2024).
Applicant's arguments filed 20 May 2025 have been fully considered but they are not persuasive. Applicant’s argue the following:
Enfamil teaches the product is not intended to diagnose, treat, cure or prevent any disease whereas the instant claims are to a therapeutic and/or prophylactic stabilized formulation (see Request for Continued Examination dated 20 May 2025, referred to herein as Remarks pg. 7, 1st and 2nd full paragraphs),
Enfamil iron supplements do not contain IgA, potassium phosphate, histidine, potassium chloride, α-lactalbumin, myristyl sulfobetaine, or protein expression extract (see Remarks pg. 7 3rd full para),
Examiner’ has not met the standard for a 35 U.S.C. 102 rejection (see Remarks pg. 8, 1st full para), and
Even if one were to combine Enfamil and breastmilk neither reference teaches histidine as a pH buffering agent nor the IgA as “dispersed” in histidine (see Remarks pg. 8 last para-pg. 9 last para).
First, Enfamil teaches mixing the liquid multivitamin supplement with breast milk to increase acceptance and The American Academy of Pediatrics (AAP) recommends 400IU of supplemental vitamin D per day beginning in the first days of life for all breastfed and partially breastfed infants” and “when added to 2 fl oz of infant formular or breast milk” (see Enfamil pg. 2 first bullet, pg. 3 last line, pg. 4 osmolality). Thus, while the liquid multivitamin supplement is not intended to diagnose, treat, cure or prevent any disease breast milk inherently performs several of these functions as evidenced by Andreas. For example, Andreas discloses “protection from invasive pathogens at the mucosal surface relies heavily on breast milk antibodies”, “breast milk lipids have been shown to inactivate a number of pathogens in vitro, including Group B streptococcus (GBS). This suggests that lipids provide additional protection from invasive infections at the mucosal surface”, and “breast milk contains SIgA antibodies specific for many different enteric and respiratory pathogens. For example, breast milk contains antibodies protective against Vibrio cholerae, Campylobacter, Shigella, Giardia lamblia and respiratory tract infections” (see Andreas pg. 631, 2nd col. 4th para, sentences spanning pgs. 630-631, pg. 631, 2nd col. last para). Therefore the combination of the liquid multivitamin supplement and breast milk taught by Enfamil is “a stabilized prophylactic and/or therapeutic formulation comprising a therapeutically effective amount of immunoglobulin A” (lines 1-2) given both are stable at room temperature and breast milk inherently comprises IgA antibodies capable of blocking pathogens thereby arriving at (see Enfamil pg. 2, 1st and 5th bullet; see The Washington State Department of Health pg. 2 table).
Second, claim 1 is drawn to a formulation comprising:
a therapeutically effective amount of IgA,
a buffering agent selected from potassium phosphate, histidine, or a combination thereof, at a pH of about 5 to about 8,
polysorbate 80, and
one or more of potassium chloride, α-lactalbumin, myristyl sulfobetaine, or protein expression extract.
The recitation of “comprising” in line 2 is open claim language wherein the formulation does not exclude additional unrecited elements (see MPEP § 2111.03(I)). Therefore, the additional elements taught by Enfamil pointed to by Applicant (e.g., Vitamin A, D, E and C) are neither here nor there. In addition, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. Merck & Co. v.Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989) (see MPEP § 2123(I), 2nd para). Enfamil discloses the liquid multivitamin drop in combination with breast milk, formula, juice, cereal or other foods and “when added to 2 fl oz of infant formula or breast milk”(see Enfamil pg. 3 last line, pg. 4 osmolality). Therefore, Enfamil discloses a combination comprising polysorbate 80 (claim 1 lines 4-5, #3 above), a therapeutically effective amount of IgA (claim 1 line 2, #1 above), α-lactalbumin (claim 1 line 6, #4 above), and histidine (claim 1 line 3) as taught by Enfamil and as evidenced by Andreas and Zhang (see Enfamil pg. 3, other ingredients; see Andreas pg. 631, 2nd col. 4th para, sentences spanning pgs. 630-631, pg. 631, 2nd col. last para; see Zhang pg. 4807, Table 4) thereby arriving at the composition of the presently claimed invention. Regarding the limitation, “wherein said formulation exhibits physical and chemical stability after mechanical agitation and/or a freeze thaw cycle”. Enfamil teaches the liquid multivitamin can be stored at room temperature or refrigerated and breast milk is inherently stable at room temperature and after mechanical agitation as evidenced by The Washington State Department of Health (see Enfamil pg. 2, 5th bullet; see The Washington State Department of Health, Feeding Stored Breastmilk 1st bullet, pg. 2 table). Furthermore, regarding the preamble (i.e., “A stabilized prophylactic and/or therapeutic formulation”), if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999); Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (see MPEP § 2111.02(II)). The language of claim 1 fully and intrinsically sets forth the components of the formulation and the conditions under which the formulation is both physically and chemically stable. Therefore, the recitation of “a stabilized prophylactic and/or therapeutic formulation” is merely the intended purpose or use of the formulation and is of no significance to claim construction.
Third, 35 U.S.C. 102 rejection requires the reference teach every aspect of the claimed invention either explicitly or impliedly. Any feature not directly taught must be inherently present (see MPEP § 2120(III)). The liquid multivitamin comprises polysorbate 80 and is stable at room temperature as explicitly taught by Enfamil (see Enfamil pg. 2, 5th bullet, pg. 3 other ingredients) while breast milk inherently comprises histidine, α-lactalbumin, a therapeutically effective amount of IgA, a pH of about 5-8, stability at room temperature and after either mechanical agitation (i.e., gentle swirl) or a freeze thaw cycle as evidenced by Andreas, Zhang, and The Washington State Department of Health (see Andreas pg. 631, 2nd col. 4th para, sentences spanning pgs. 630-631, pg. 631, 2nd col. last para; see Zhang pg. 4807, Table 4; see Feeding Stored Breastmilk 1st bullet, pg. 2 table). Therefore, Enfamil teaches every aspect of the claimed invention.
Fourth, Applicant’s argues the combination of the liquid multivitamin and breast milk mixed in a bottle is not equivalent to a stabilized prophylactic and/or therapeutic formulation comprising a therapeutically-effective amount of IgA dispersed in a histidine pH buffering agent(see Remarks pg. 9, 1st para and last para). Applicant asserts “it is clear that the relative amounts of these components doesn’t even cause the skilled person to ‘envisage’ IgA being ‘dispersed’ in a histidine (as a pH buffering agent or otherwise)” (see Remarks pg. 9 last para). The specification does not provide a limiting definition for “dispersed” and therefore is given its plain and customary meaning as understood by the ordinary artisan (see MPEP § 2111). Dispersed in chemistry refers to the more or less evenly distribution through a medium (see Definitions: Dispersed. Merriam Webster, accessed online September 4, 2025, in particular pg. 1 definition 2c). Therefore, “the therapeutically effective amount of IgA dispersed in a pH buffering agent” as instantly claimed naturally flows from mixing the liquid multivitamin in a bottle of breastmilk resulting in a homogenous mixture. Regarding histidine as a pH buffering agent, the histidine recited in the claim is not structurally different from the histidine found in breast milk. Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the histidine found in breastmilk is a buffering agent as instantly claimed. Furthermore, Applicant asserts “histidine is almost non-existent in free amino acid form” and appears to imply histidine as part of a larger structure loses buffering capacity (see Remarks pg. 9, 2nd para). However, Zheng teaches free histidine is present in µmol concentration in breast milk while total histidine is present in mg/100ml concentrations (see Zheng Table 5). In so far as Applicant is asserting histidine loses buffering capacity when part of a larger structure, Applicant provides no objective evidence or sound scientific reasoning to support such a contention; rather, it appears to be nothing more than attorney argument. As set forth in the MPEP at 2145, "The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
The 35 U.S.C. 102(a)(1) rejection of claims 1-3, 6-9, 35, 36, 40, 41, 43, 44, 48, 60, and 61 is hereby maintained.
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 (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 1-3, 6-9, 35, 36, 40, 43, 44, 48, 60, and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Enfamil® (as cited on the PTO-892 dated 21 November 2024) and Supplementing (as cited on the PTO-892 dated 21 November 2024) as evidenced by Andreas, Zhang, Kim, The Washington State Department of Health (as cited on PTO-892 dated 21 March 2024), and FMLA US Dept Of Labor (see as cited on the PTO-892 dated 21 November 2024).
Applicant's arguments filed 20 May 2025 have been fully considered but they are not persuasive.
Applicant’s argue the same reasons as stated above and that there is no apparent reason to combine (see Remarks pg. 10, 3rd para and last full para).
As stated in the Final Office Action dated 24 November 2024:
“Therefore, given the US allows up to 12 weeks of unpaid job protected leave per year under the Family and Medical Leave Act as evidenced by FMLA (see FMLA US Dept Of Labor) a person of ordinary skill in the art (i.e., a working mom) would combine Enfamil A+ Infant Formula with breast milk and the Enfamil® Poly-Vi-Sol® (daily vitamin with iron) in order to prepare baby for the upcoming transition to child care. In combining the formula, breast milk, and multi-vitamin, mom is adjusting baby to the taste of formula as suggested by Supplementing while ensuring baby is maintaining proper intake of nutrients from the multivitamin and breast milk; thereby arriving at the presently claimed invention”. For the reasons stated above in the 35 U.S.C. 102(a)(1) rejection and for the reasons made of record the 35 U.S.C. 103 rejection of claims 1-3, 6-9, 35, 36, 40, 43, 44, 48, 60, and 61 is hereby maintained.
Claims 1-3, 6-12, 35, 36, 40, 43, 48, 60, and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Enfamil® (as cited on the PTO-892 dated 21 November 2024) and Hein (as cited on the PTO-892 dated 21 March 2024) as evidenced by Andreas, Zhang, Kim, and The Washington State Department of Health (as cited on PTO-892 dated 21 March 2024).
Applicant's arguments filed 20 May 2025 have been fully considered but they are not persuasive.
Applicant argues for the reasons listed above and also notes Hein is additionally deficient. Specifically Hein i. uses polysorbate 20 for purposes other than developing a formulation comprising IgA, ii. does not use potassium phosphate or histidine, iii. all the examples are prophetic, and iv. no evidence of assembled sIgA (see Remarks para spanning pgs. 11-12).
First, 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). Enfamil and Supplementing was relied upon for teaching polysorbate 80, histidine, and potassium phosphate.
Second, even if Hein’s examples are all prophetic, the courts have further cautioned that the presence of prophetic examples alone should not be the basis for asserting that a specification is not enabling; rather, a lack of operative embodiments and undue experimentation should be determinative. Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984) (see MPEP §2164.02). Hein discloses how to both make and use the IgA antibodies. Specifically teaching,
“As previously determined, modification of the heavy chain by replacement of its Cγ3 domain with Cα2 and Cα3 domains from an IgA-secreting hybridoma (MOP315) did not affect the assembly or function of the antibody (IgA-G) produced in transgenic plants (Ma, et al., Id).” (see Hein col. 66 line 11-17) and
“These results confirm that SC (i.e., fourth polypeptide, secretory component) was assembled with antibody in the SIgA-G plant but did not interfere with antigen recognition or binding” (see Hein col. 71 lines17-21).
While, Hein may have reduced to practice production of IgA antibodies in tobacco leaves, Hein also teaches using a transgenic plant generically for administration in infant formula and adults (see Hein col. 65 lines 11-21). Hein also discloses several other sources of transgenic plants, “Commercially important cereal grains such as rice, corn and wheat must be transformed using alternative methods. Transformation of plant protoplasts can be achieved using methods based on calcium phosphate precipitation, polyethylene glycol treatment, electroporation and combinations of these treatments” and subsequently points to several references for specific methods (see Hein col. 14 lines 40-51). In addition, Hein claims a transgenic plant comprising immunoglobulin molecules wherein the immunoglobulin molecule is an IgA and wherein the plant is a dicotyledonous plant or monocotyledonous plant (see Hein claims 19, 23, 24, and 33).
Therefore, for the reasons stated above (i.e., Response to arguments presented regarding 35 U.S.C. 102(a)(1)) and here the 35 U.S.C. 103 rejection of claims 1-3, 6-12, 35, 36, 40, 43, 48, 60, and 61 is hereby maintained.
Claims 1-3, 6-13, 35, 36, 40, 43, 48, 60, and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Enfamil® (as cited on the PTO-892 dated 21 November 2024), Hein (as cited on the PTO-892 dated 21 March 2024), and Hofmann (as cited on the PTO-892 dated 03/21/2024) as evidenced by Andreas, Zhang, Kim, and The Washington State Department of Health (as cited on PTO-892 dated 21 March 2024).
Applicant's arguments filed 20 May 2025 have been fully considered but they are not persuasive.
Applicant argues Hoffman does not remedy the deficiencies set forth above (see Remarks pg. 12 last para).
Therefore, for the reasons set forth above the 35 U.S.C. 103 rejection of claims 1-3, 6-13, 35, 36, 40, 43, 48, 60, and 61 is hereby maintained.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Douillard (see Douillard 2018 Whey Pure Protein Powder) and Umpqua (see Umpqua Ice Cream 2016 Chocolate Peanut Butter Ice Cream) as evidenced by Tarantola and Wujastyk. (see Tarantola and Wujastyk 2009. Alternative Milk Beverages. Journal of Renal Nutrition, Vol 19, No 2 (March), 2009: pp e1–e10).
Applicant's arguments filed 20 May 2025 have been fully considered but they are not persuasive.
Applicant argues the rejection suffers i. similar deficiencies as above (e.g., the presence of histidine as a pH buffering agent), ii. Douillard does not disclose a particular amount of IgA, iii. there is no evidence the composition would exhibit physical and chemical stability (see Remarks pg. 13, 2nd full para), and iv. Applicant’s working examples (see Remarks pg. 14, 1st full para-2nd full para).
First, see above regarding histidine as a pH buffering agent and the therapeutically effective amount of IgA is dispersed. It is also noted Douillard teaches Whey Pure comprises α-lactalbumin (see Douillard pg. 6, 3rd para), about 140mg of potassium (see Douillard pg. 13 table), and 380mg of histidine (see Douillard pg. 14 table) in 20g of Whey Pure Protein Powder. There is no evidence the histidine taught by Douillard is structurally different from the instantly claimed histidine. Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the histidine found in Douillard is a buffering agent as recited in the instant claims. The language of claim 1 requires the formulation to have physical and chemical stability after either mechanical agitation and/or a freeze thaw cycle (see claim 1 last 2 lines; see Remarks pg. 13, 2nd full para). Therefore, given a protein shake is shaken to mix the various ingredients the prior art renders obvious mechanical agitation.
Second, Applicant asserts “there is no evidence that the composition would exhibit physical and chemical stability” (see Remarks pg. 13, 2nd full para). However, Applicant provides no objective evidence or sound scientific reasoning to support such a contention; rather, it appears to be nothing more than attorney argument. As set forth in the MPEP at 2145, "The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). Furthermore, Douillard teaches “to maintain the protein activity level, do not mix in hot drinks or recipes that require baking or boiling. Also, do not mix with pineapple or papaya because their enzymes may deactivate the protein” (see Douillard pg. 3, directions). Therefore, Douillard suggests absent these conditions the Whey Pure Protein is stable.
Third, Applicant asserts a skilled person would not consider the whey protein shake made with ice cream to be analogous to a prophylactic and/or therapeutic formulation” (see Remarks pg. 13, 2nd para). However, again Applicant provides no objective evidence or sound scientific reasoning to support such a contention; rather, it appears to be nothing more than attorney argument. As set forth in the MPEP at 2145, "The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). In addition, regarding the preamble (i.e., “A stabilized prophylactic and/or therapeutic formulation”), if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999); Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (see MPEP § 2111.02(II)). The language of claim 1 fully and intrinsically sets forth the components of the formulation and the conditions under which the formulation is both physically and chemically stable. Therefore, the recitation of “a stabilized prophylactic and/or therapeutic formulation” is merely the intended purpose or use of the formulation and is of no significance to claim construction. It is noted, Sundell published a Review in Advances in Preventive Medicine regarding the importance of resistance training in combating Metabolic Syndrome which increases markedly the risk of arteriosclerotic vascular disease (see Sundell, Jan, Resistance Training Is an Effective Tool against Metabolic and Frailty Syndromes, Advances in Preventive Medicine, 2011, 984683, 7 pages, 2011, abstract). Sundell specifically teaches a whey protein shake immediately following exercise given both protein uptake and protein usage are increased at this time in order to minimize the protein malnutrition in subjects with metabolic and frailty syndromes (see Sundell pg. 4 table 3, pg. 5, 1st col. sec 4.3). Therefore, contrary to Applicant’s assertion, a person of ordinary skill in the art would consider a “whey protein shake” as a stabilized prophylactic therapeutic formulation.
Fourth, Applicant points to working examples to demonstrate the technical analysis and formulation work involved in the stabilized prophylactic and/or therapeutic formulation. Specifically, Applicant asserts “Claim 1 closely aligns with particular formulations having optimal excipients” and that only 1 of 4 sulfobetaines had acceptable recovery of the intact protein (see Remarks pg. 13, 1st and 2nd full para). However, no single claim limits the formulation to wherein the stabilizing agent is said sulfobetaine (i.e., myristyl). Therefore, the allegedly unexpected results of formulations with myristyl sulfobetaine are limitations not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
It is also noted, the language of claim 1 is drawn to a genus of formulations comprising at least 2 buffers or any combination thereof (e.g., concentration), a genus of IgA structures (see specification pg. 10, 1st full para), and any combination of up to four stabilizing agents wherein one of the stabilizing agents is also a genus (i.e., protein expression extract).
New Claim Objections
Claims 2, 7, 35, and 44 are objected to because of the following informalities:
Claim 2 recites “and storage, and has at least” in lines 2-3 and should recite, “storage, and has at least”.
Claim 7 recites “sIgA” in line 2 and should recite “secretory IgA (sIgA)”.
Claim 35 recites “said immunoglobulin” in line 2 and should recite, “said immunoglobulin A”.
Claim 44 recites “and said polysorbate 80, and said potassium” in lines 2-3 and should recite, “said polysorbate 80, and said potassium”.
Appropriate correction is required.
New 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 1-3, 6-13, 35, 36, 40, 41, 43, 48, 60, and 61 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.
The term “about” in claims 1, 3, 6 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The following is unclear:
what pH is within the scope of about 5 or about 8 (claim 1),
what temperature is within the scope of about 25°C (claim 3),
what amount of time is within the scope of about 6 months (claim 3), and
what mount of IgA is within the scope of about 200mg/ml.
Claim 36 is drawn to wherein said protein expression extract is unpurified. The broadest reasonable interpretation of extract is to draw forth (Definition: Extract, Merriam Webster, accessed online 5 September 2025). Therefore by definition protein expression extract has undergone some degree of purification. It is unclear how the protein expression extract can also be unpurified.
Claim 40 contains the trademark/trade name “Pluronic®”. 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 product the stabilized prophylactic and/or therapeutic formulation is substantially free of and, accordingly, the identification/description is indefinite (see Trademark Pluronic, Goods and Services tab, accessed online 2 September 2025). Pursuant to MPEP 2173.05(u) second paragraph,
“If the 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 the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). See also Eli Lilly & Co. v. Apotex, Inc., 837 Fed. Appx. 780, 784-85, 2020 USPQ2d 11531 (Fed. Cir. 2020)”.
Claim 43 recites the limitation "said recombinant IgA" in line 2. There is insufficient antecedent basis for this limitation in the claim.
In addition, claim 43 is drawn to wherein said recombinant IgA in said protein expression extract. The scope of the recombinant IgA is unclear. For example, is the IgA isolated from protein expression extract or alternatively the IgA can be from any source and the stabilizing agent is protein expression extract.
Claim 44 is drawn to said histidine buffering agent pH 6.0±0.2. It is unclear if the stabilized prophylactic and/or therapeutic formulation has a pH of 6.0±0.2 or alternatively is the pH 6.0±0.2 specifically related to histidine.
Conclusion
No claim allowed.
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/H.A.P./Examiner, Art Unit 1644 /AMY E JUEDES/Primary Examiner, Art Unit 1644