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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09 January 2026 has been entered.
Status of the Claims
Applicant’s submission filed 09 January 2026 has been entered. Claims 1-28, 30-34, and 37-42 are pending. Claims 24, 30, and 32-34 have been amended, while claims 35-36 have been cancelled without prejudice or disclaimer and claims 37-42 have been newly added. Therefore, prosecution on the merits continues for claims 24-28, 30-34, and 37-42 as being drawn to the elected invention, with claims 1-23 withdrawn for reading on the non-elected invention(s). All arguments have been fully considered with the status of each prior ground of rejection set forth below.
Status of Prior Rejections/Response to Arguments
RE: Objection to claims 24, 30, and 32-33
Applicant’s amendments to each of claims 24, 30, and 32-33 correct the minor informalities of the claims, thus obviating the objections of record.
Therefore, the objections are withdrawn.
RE: Rejection of claims 24-28 and 30-33 under 35 USC 112(b)
Applicant’s amendments to independent claim 25 correct the antecedent basis of the claim, thus obviating the rejection of record.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 24-28 and 30-32 under 35 USC 102(a)(1) over O’Dea et al
Applicant has traversed the rejection, asserting in Page 10 of the Remarks filed 09 January 2026 that O’Dea et al fail to teach an isotonic solution. In response, the Examiner respectfully submits that O’Dea et al disclose a delivery solution that is considered hypotonic, as evidenced by the cell swelling in Figure 8 representing the mechanism of action. Accordingly, Applicant’s arguments have been fully considered and are found persuasive.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 24-28 and 30-33 under 35 USC 103 over O’Dea et al
Applicant has traversed the rejection, asserting in Pages 11-12 of the Remarks filed 09 January 2026 that O’Dea et al fail to teach an isotonic solution, and instead teach a hypotonic delivery solution. In response, the Examiner respectfully submits that O’Dea et al disclose a delivery solution that is considered hypotonic, as evidenced by the cell swelling in Figure 8 representing the mechanism of action. Accordingly, Applicant’s arguments have been fully considered and are found persuasive.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 34-36 under 35 USC 103 over Maguire et al as evidenced by Milone et al
Applicant has amended independent claim 34 to require the population of non-adherent immune cells to be unactivated. With that, Applicant has traversed the rejection, asserting in Pages 12-13 of the Remarks filed 09 January 2026 that Maguire et al fail to teach the delivery of an isotonic solution comprising exogenous cargo to unactivated immune cells, and instead only deliver the isotonic solution to activated immune cells. In response, the Examiner respectfully submits that although Maguire et al disclose that the immune cells can be optionally activated, Maguire et al fail to reduce to practice the administration of an isotonic solution comprising exogenous cargo to unactivated immune cells. Accordingly, the ordinary artisan cannot predictably arrive to the methods as claimed given the disclosure of Maguire et al.
Therefore, the rejection is withdrawn.
New Grounds of Rejection
Claim Objections
Claim 34 is objected to because of the following informalities:
Regarding claim 34: The instant claim is objected to for reciting “(i) an intracellular delivery method comprising of contacting the population of cells…” in Line 5. Applicant must correct the limitation to instead recite “(i) an intracellular delivery method comprising [[of]] contacting the population of cells…”, “(i) an intracellular delivery method comprised of contacting the population of cells…”, or the like.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 24-28, 30-34, and 37-42 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 claims contain subject matter which was not described in the Specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for 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 24 is directed to a method of engineering a non-adherent immune cell, the method comprising,
(a) providing a population of non-adherent immune cells; and
(b) contacting the population of non-adherent immune cells with a volume of an isotonic aqueous solution, the aqueous solution including exogenous cargo and an alcohol at greater than 0.2 percent (v/v) concentration, wherein the population of non-adherent immune cells is unactivated during (a) and (b),
wherein an immune function of the population of non-adherent immune cells from steps (a) and (b) is that of a population of non-adherent immune cells that has not experienced a cell engineering step, and
wherein the immune cell function comprises gene expression of T-cell exhaustion related genes comprising FBJ murine osteosarcoma viral oncogene homolog B (FOSB), v-Fos FBJ Murine Osteosarcoma Viral Oncogene (FOS), v-jun avian sarcoma virus 17 oncogene (JUN), Basic leucine zipper transcription factor ATF-like (BATF), Basic leucine zipper transcriptional factor ATF-like 3 (BATF3), or Interferon regulatory factor 4 (IRF4).
With that, independent claim 34 is directed to a method of delivering at least two exogenous cargos across the plasma membrane of a non-adherent immune cell, comprising
(a) providing a population of non-adherent immune cells,
(b) using at least two intracellular delivery methods comprising:
(i) an intracellular delivery method comprising of contacting the population of cells with a volume of an isotonic aqueous solution, the aqueous solution including the exogenous cargo and an alcohol at greater than 0.5 percent (v/v) concentration, wherein the population of non-adherent immune cells is unactivated, and
(ii) an intracellular delivery method selected from (1) contacting the population of cells with a volume of an isotonic aqueous solution, the aqueous solution including the exogenous cargo and an alcohol at greater than 0.5 percent (v/v) concentration, (2) viral transduction, (3) electroporation, or (4) nucleofection,
wherein an immune function of the population of non-adherent immune cells from steps (a) and (b) is that of a population of non-adherent immune cells that has not experienced a cell engineering step, and
(c) thereby delivering the two exogenous cargos to the non-adherent immune cell.
Thus, to satisfy the written description aspect of 35 U.S.C. 112(a) for a claimed group – or genus – of unactivated non-adherent immune cells, isotonic aqueous solutions, and immune functions, MPEP §2163 recites, “[t]he written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus…when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.”
The written description inquiry is limited to that which is contained within the four corners of the Specification, not the extent to which the skilled artisan, given his or her knowledge of the art, would have considered it to expand with only routine experimentation. See Ariad Pharms. Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010); see also id. at 1352 (“[I]t is the specification itself that must demonstrate possession. . . . a description that merely renders the invention obvious does not satisfy the requirement.").
Regarding disclosure of identifying characteristics of the claimed groups, a review of the Specification fails to provide a definition of the structural characteristics the species encompassed by the current claims must have. As such, Applicant has failed to identify any particular core chemical structure or function (along with a correlation between function and a specific conserved structure) of the non-adherent immune cells, isotonic aqueous solutions, and immune functions; and thus one of ordinary skill in the art would not immediately envisage all possible species of the groups as currently claimed. Therefore, Applicant has not disclosed the identifying characteristics of the claimed groups.
More specifically, in giving the terms ‘unactivated non-adherent immune cell’, ‘isotonic aqueous solution’, and ‘immune function’ their broadest reasonable interpretation, the number and types of cells, solutions, and functions which can be considered a species of their respective group is extraordinarily great, as they can include any type of unactivated non-adherent immune cell, any isotonic aqueous solution comprising any type of alcohol at any concentration up to 100 percent that is greater than the claimed lower bound, and any immune function (in regards to claim 34 and dependents thereof). Applicant’s disclosure does not provide any definitions for the respective groups, instead broadly stating within Paragraph [0006] of the published Specification that an “immune cell can be, for example, a T-cell, NK-cell, B-cell, macrophage, or other immune cell”, while Paragraphs [0046] and [0060]-[0061] of the published Specification detail that the aqueous solution is “isotonic with respect to the cytoplasm of a mammalian cell such as a human T cell” and can preferably comprise 25 percent (v/v) of an alcohol, wherein an “alcohol is a polyatomic organic compound including one hydroxyl functional group attached to at least one carbon atom”. The same is true for the ‘immune functions’, as Applicant broadly states in Paragraph [0040] of the published Specification that the immune functions of the non-adherent immune cell can “comprise a phenotype of a cell that has not experienced a cell engineering step, wherein the immune function is selected from (i) cytokine release; (ii) gene expression, and (iii) metabolic rate”, while Paragraph [0157] of the published Specification suggests that the immune functions include the phenotype, cytokine release, gene expression, or metabolic rate of the cells.
The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon "reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter." Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)). Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). See M.P.E.P. § 2163.02. In this case, the skilled artisan would not have reasonably concluded at the time of the invention that applicant was in possession of the entire invention as claimed.
Applicant’s disclosure also fails to provide a sufficient number of exemplary unactivated non-adherent immune cells, isotonic aqueous solutions, and immune functions given the breadth of each respective genus. More specifically, Applicant has provided a single working example of treating unactivated non-adherent T cells with a single isotonic aqueous solution and examined the expression of genes related to immune cell exhaustion, activation, and persistence. However, it is of note that the unactivated non-adherent T cells within this working example were mock-transfected such that the isotonic aqueous solution did not comprise an exogenous cargo or concentration of alcohol, which does not read on the methods of the instant claims. See Example 4 and Paragraphs [0242]-[0243] of the published disclosure.
The written description requirement is in place to ensure that “when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function.” Ariad Pharms. Co. v. Eli Lilly & Co., 94 U.S.P.Q.2d 1161, 1172 (Fed. Cir. 2010) (en banc). A consideration of the four corners of the Specification does not reflect that Applicant has actually invented the scope of the claimed invention, since the working examples are primarily limited to the treatment of activated T cells or PBMCs with a single isotonic aqueous solution comprising a concentration of ethanol and examination of a relatively minute number of immune functions. With that, the lone working example utilizing unactivated non-adherent T cells that have been treated with a single isotonic aqueous solution – which does not comprise an alcohol – and examined for exhaustion/proliferation/activation markers is not sufficient to fulfill the written description requirement for a sufficient description of a representative number of species, which is required to claim the entire genus of “an unactivated non-adherent immune cell” that has been treated with “an isotonic aqueous solution comprising an alcohol” and has an unchanged “immune function”, as required by the instant claims. Additionally, there is no disclosure of relevant, identifying characteristics, such as structure or other physical or chemical properties, or functional characteristics sufficient to show that Applicant was in possession of the claimed genera. See Eli Lilly, 119F. 3d. at 1568, 43 USPQ2d at 1406, and MPEP § 2163. Therefore, the Specification does not permit the skilled artisan to visualize all of the members of the genus being administered in the claimed methods.
If claims merely recite a “description of the problem to be solved while claiming all solutions to it” and “cover any compound later actually invented and determined to fall within the claim’s functional boundaries,” they have not met the description requirement. Ariad, 94 U.S.P.Q.2d at 1172.
Furthermore, the Examiner notes that the prior art in regards to the claims is unpredictable. More specifically, there are inherent structural and functional differences between unactivated and activated immune cells. Berard et al disclose that unactivated – or naïve – T cells have a lower expression of adhesion and migratory molecules when compared to activated T cells, which affect their ability to migrate to non-lymphoid tissues and respond to antigens – or their immune function. See Pages 127, 129-130 of Berard et al (Immunology, 2002). With that, O’Dea et al disclose that aqueous solutions comprising high concentrations of ethanol are toxic to the treated immune cells. See Pages 2-3 and 7 of O’Dea et al (PLOS ONE, 2017, of record). It is also of note that the published Specification suggests that extrapolating data from the working examples to a generic teaching is not predictable, as the comparison of gene expression in the cells differed when represented by log 2 fold change or linear fold change. See Paragraphs [0081]-[0084] and Figure 12 of the published Specification.
Accordingly, Applicant’s disclosure appears to be an investigation of a mechanism wherein treatment of unactivated non-adherent T cells with an isotonic solution comprising ethanol does not alter the immune function of the unactivated non-adherent T cells. However, [p]atents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others.” Ariad, 94 U.S.P.Q.2d at 1173. The patent system is designed to give incentives to complete inventions, not to guess at the future. Id. at 1174.
Taken together, the lack of disclosure of species, lack of an established structure-function relationship in the Specification or prior art, and unpredictability of the prior art, a skilled artisan would not conclude that Applicant was in possession of the claimed invention. Accordingly, the claims are considered to lack sufficient written description and are properly rejected under 35 USC 112(a). Claims 25-28, 30-33, and 37-42 are included because they depend from a rejected claim and also lack sufficient written description.
Claims 24-28, 30-34, and 37-42 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the Specification, while being enabling for the treatment of activated T cells with an isotonic aqueous solution comprising ethanol and having an unaltered immune function when compared to an untranslated control, does not reasonably provide enablement for the treatment of any unactivated non-adherent immune cell with any isotonic aqueous solution comprising any alcohol and having an unaltered immune function when compared to any population of non-adherent immune cells that has not experienced a cell engineering step. The instant Specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims, as the instant claims are directed to a method of engineering a non-adherent immune cell (emphasis added).
Possession of an invention may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998). Although working examples are not required, the claimed invention is required to be enabled so that any person skilled in the art can make and use the invention without undue experimentation. See MPEP § 2164.
The factors to be considered in determining whether a disclosure would require undue experimentation include:
A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP § 2164.01.
Nature of the invention: Independent claim 24 is directed to a method of engineering a non-adherent immune cell, the method comprising,
(a) providing a population of non-adherent immune cells; and
(b) contacting the population of non-adherent immune cells with a volume of an isotonic aqueous solution, the aqueous solution including exogenous cargo and an alcohol at greater than 0.2 percent (v/v) concentration, wherein the population of non-adherent immune cells is unactivated during (a) and (b),
wherein an immune function of the population of non-adherent immune cells from steps (a) and (b) is that of a population of non-adherent immune cells that has not experienced a cell engineering step, and
wherein the immune cell function comprises gene expression of T-cell exhaustion related genes comprising FBJ murine osteosarcoma viral oncogene homolog B (FOSB), v-Fos FBJ Murine Osteosarcoma Viral Oncogene (FOS), v-jun avian sarcoma virus 17 oncogene (JUN), Basic leucine zipper transcription factor ATF-like (BATF), Basic leucine zipper transcriptional factor ATF-like 3 (BATF3), or Interferon regulatory factor 4 (IRF4).
With that, independent claim 34 is directed to a method of delivering at least two exogenous cargos across the plasma membrane of a non-adherent immune cell, comprising
(a) providing a population of non-adherent immune cells,
(b) using at least two intracellular delivery methods comprising:
(i) an intracellular delivery method comprising of contacting the population of cells with a volume of an isotonic aqueous solution, the aqueous solution including the exogenous cargo and an alcohol at greater than 0.5 percent (v/v) concentration, wherein the population of non-adherent immune cells is unactivated, and
(ii) an intracellular delivery method selected from (1) contacting the population of cells with a volume of an isotonic aqueous solution, the aqueous solution including the exogenous cargo and an alcohol at greater than 0.5 percent (v/v) concentration, (2) viral transduction, (3) electroporation, or (4) nucleofection,
wherein an immune function of the population of non-adherent immune cells from steps (a) and (b) is that of a population of non-adherent immune cells that has not experienced a cell engineering step, and
(c) thereby delivering the two exogenous cargos to the non-adherent immune cell.
The relative skill of those in the art: The relative skill of those in the art is high, with the majority of ordinary artisans possessing an advanced degree.
The breadth of the claims: With respect to claim breadth, the standard under 35 U.S.C. §112(a) entails the determination of what the claims recite and what the claims mean as a whole. In addition, when analyzing for enablement, the claims are analyzed with respect to the teachings of the Specification and are to be “given their broadest reasonable interpretation consistent with the Specification.” See MPEP § 2111 [R-5]; Phillips v. AWH Corp., 415 F.3d 1303, 75 USPQ2d 1321 (Fed. Cir. 2005); and In re Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the Examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550- 51 (CCPA 1969).
As such, the broadest reasonable interpretation of the instantly claimed methods includes any type of unactivated non-adherent immune cell, any isotonic aqueous solution comprising any type of alcohol at any concentration up to 100 percent that is greater than the claimed lower bound, and any immune function (in regards to claim 34 and dependents thereof). A skilled artisan would not know how to engineer a non-adherent immune cell with a reasonable expectation of success based solely on what is disclosed in the Specification.
The amount of direction or guidance presented: The instant Specification fails to exemplify the engineering of an unactivated non-adherent immune cell, wherein the unactivated non-adherent immune cell is contacted with an isotonic aqueous solution comprising a concentration of an alcohol. Instead, the closest working example contacts unactivated non-adherent T cells with an isotonic aqueous solution that does not comprise alcohol or an exogenous cargo. See Example 4, which correlates to Paragraphs [0209]-[0220] of the published Specification. This fails to provide specific details necessary to successfully perform the full scope of the claimed method.
The presence or absence of working examples: As aforementioned, the instant Specification only provides working examples either for the engineering of activated non-adherent T cells with an isotonic aqueous solution comprising a concentration of ethanol, or for the mock-transfection of unactivated non-adherent T cells using an isotonic aqueous solution that does not comprise alcohol or an exogenous cargo. See Example 4, which correlates to Paragraphs [0209]-[0220] of the published Specification. Therefore, Applicant has not provided sufficient evidence of the engineering of any unactivated non-adherent immune cell using any isotonic aqueous solution comprising any alcohol.
The level of predictability in the art and quantity of experimentation necessary: The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success. A patent is granted for a completed invention, not the general suggestion of an idea and how that idea might be developed into the claimed invention.
The prior art appears to be silent with regard to demonstrating the engineering of unactivated non-adherent immune cells with an isotonic aqueous solution comprising an alcohol. More specifically, the disclosure of O’Dea et al (PLOS ONE, 2017, of record) utilizes a hypotonic aqueous solution comprising 25% ethanol on unactivated non-adherent T cells, while the disclosure of Maguire et al (WO 2018/115973 A2, of record) engineers activated non-adherent immune cells using an isotonic aqueous solution comprising 27% ethanol. Given that the use of unactivated versus activated immune cells is unpredictable – which Applicant has persuasively argued in Pages 10-12 of the Remarks filed 26 June 2025 and Pages 12-13 of the Remarks filed 09 January 2026, and is suggested in Pages 127, 129-130 of Berard et al (Immunology, 2002) – the full scope of the claim terms "non-adherent immune cell", “isotonic aqueous solution including… an alcohol”, and “immune function” is thus not enabled in regards the engineering of a non-adherent immune cell, since at best it would require undue trial and error experimentation.
Claims 25-28, 30-33, and 37-42 are included because they depend from a rejected claim and do not enable the recited claim language. See MPEP § 2164.08.
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 24-28, 30-34, and 37-42 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.
Regarding claims 24-28, 30-33, and 37-38: Independent claim 24 recites the limitation, “wherein an immune function of the population of non-adherent immune cells from steps (a) and (b) is that of a population of non-adherent immune cells that has not experienced a cell engineering step” in Lines 8-10. The scope of the claim is indefinite, as it is unclear whether the “population of non-adherent immune cells that has not experienced a cell engineering step” is the same type of non-adherent immune cell that has been engineered, or a different type of non-adherent immune cell. In other words, the ordinary artisan cannot readily determine whether the engineered non-adherent immune cells are being compared to a control non-adherent immune cell – or a population of the non-adherent immune cells that has not experienced being contacted with the isotonic aqueous solution – or any type of non-adherent immune cell that has undergone any type of cell engineering. Therefore, the metes and bounds of the claim cannot be determined, thus rendering the scope of the claim indefinite.
Instant claims 25-28, 30-33, and 37-38 are included in the rejection because they depend from rejected claim 24.
Appropriate correction is required.
Regarding claims 34 and 39-42: Independent claim 34 recites the limitation, “wherein an immune function of the population of non-adherent immune cells from steps (a) and (b) is that of a population of non-adherent immune cells that has not experienced a cell engineering step” in Lines 14-16. The scope of the claim is indefinite, as it is unclear whether the “population of non-adherent immune cells that has not experienced a cell engineering step” is the same type of non-adherent immune cell that has been engineered, or a different type of non-adherent immune cell. In other words, the ordinary artisan cannot readily determine whether the engineered non-adherent immune cells are being compared to a control non-adherent immune cell – or a population of the non-adherent immune cells that has not experienced being contacted with the isotonic aqueous solution and other intracellular delivery method selected from (1)-(4) – or any type of non-adherent immune cell that has undergone any type of cell engineering. Therefore, the metes and bounds of the claim cannot be determined, thus rendering the scope of the claim indefinite.
Instant claims 39-42 are included in the rejection because they depend from rejected claim 34.
Appropriate correction is required.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (CT).
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, Christopher Babic can be reached at (571) 272-8507. 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.
/ALYSSA G WESTON/Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633